{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Micromedics, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/micromedics-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/micromedics-inc",
    "json_url": "https://devicerts.com/manufacturers/micromedics-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/micromedics-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/micromedics-inc",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Micromedics, Inc.",
    "url": "https://devicerts.com/manufacturers/micromedics-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000018365"
      },
      {
        "label": "FDA FEI",
        "value": "2183425"
      },
      {
        "label": "DUNS",
        "value": "066839630"
      }
    ],
    "summary": "Micromedics, Inc. is a medical device manufacturer based in the United States, with 221 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class IIa; FDA Class II, Class I and Unclassified) and 5 FDA recalls as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 221,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 5,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 154
      },
      {
        "registry": "EUDAMED",
        "devices": 118
      },
      {
        "registry": "FDA 510(k)",
        "devices": 28
      }
    ],
    "device_classes": [
      {
        "class": "EU Class IIa",
        "devices": 118
      },
      {
        "class": "FDA Class II",
        "devices": 66
      },
      {
        "class": "FDA Class I",
        "devices": 34
      },
      {
        "class": "FDA Unclassified",
        "devices": 2
      }
    ],
    "top_emdn_categories": [
      {
        "code": "A02",
        "name": "Syringes",
        "url": "https://devicerts.com/categories/emdn/A02",
        "devices": 114
      },
      {
        "code": "A03",
        "name": "Tubular devices",
        "url": "https://devicerts.com/categories/emdn/A03",
        "devices": 4
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "MDSS GmbH",
        "url": "https://devicerts.com/representatives/mdss-gmbh-de-ar-000005430",
        "country": "Germany"
      }
    ]
  },
  "devices": {
    "shown": 50,
    "total": 221,
    "all_devices_url": "https://devicerts.com/manufacturers/micromedics-inc",
    "items": [
      {
        "name": "Applicator Tip",
        "url": "https://devicerts.com/devices/applicator-tip-sa-3618",
        "model_reference": "SA-3618",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Instru-Safe Instrument Protection Systems",
        "url": "https://devicerts.com/devices/instru-safe-instrument-protection-systems-kct",
        "model_reference": "K051157",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2005-09-01",
        "open_recall": false
      },
      {
        "name": "FibriJet",
        "url": "https://devicerts.com/devices/fibrijet-sa-3647-a058e0d6",
        "model_reference": "SA-3647",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet",
        "url": "https://devicerts.com/devices/fibrijet-sa-3671-f09a61c4",
        "model_reference": "SA-3671",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet",
        "url": "https://devicerts.com/devices/fibrijet-800-0251-827eb846",
        "model_reference": "800-0251",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "DuploTip",
        "url": "https://devicerts.com/devices/duplotip-0601137-0c9746b2",
        "model_reference": "0601137",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3668",
        "url": "https://devicerts.com/devices/fibrijet-sa-3668",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biomet 800-0217",
        "url": "https://devicerts.com/devices/biomet-800-0217",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet SA-3646",
        "url": "https://devicerts.com/devices/fibrijet-sa-3646",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osteoprecision Gd-1015-100",
        "url": "https://devicerts.com/devices/osteoprecision-gd-1015-100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Mitek Sports Medicine 278014",
        "url": "https://devicerts.com/devices/mitek-sports-medicine-278014",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pramand FS-2005",
        "url": "https://devicerts.com/devices/pramand-fs-2005",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3654",
        "url": "https://devicerts.com/devices/fibrijet-sa-3654",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet SA-3625",
        "url": "https://devicerts.com/devices/fibrijet-sa-3625",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duplotip SA374003000000",
        "url": "https://devicerts.com/devices/duplotip-sa374003000000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gasless Tip 601153",
        "url": "https://devicerts.com/devices/gasless-tip-601153",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet AMS700-B",
        "url": "https://devicerts.com/devices/fibrijet-ams700-b-bef559b6",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-6205",
        "url": "https://devicerts.com/devices/fibrijet-sa-6205",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Baxter 0600128",
        "url": "https://devicerts.com/devices/baxter-0600128",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biomet Biologics 800-0211",
        "url": "https://devicerts.com/devices/biomet-biologics-800-0211",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OsteoPrecision GD-1015-100-CC",
        "url": "https://devicerts.com/devices/osteoprecision-gd-1015-100-cc",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3658",
        "url": "https://devicerts.com/devices/fibrijet-sa-3658",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet SA-6111",
        "url": "https://devicerts.com/devices/fibrijet-sa-6111",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osteoprecision Gd-1215-050",
        "url": "https://devicerts.com/devices/osteoprecision-gd-1215-050",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Baxter 0600225",
        "url": "https://devicerts.com/devices/baxter-0600225",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duplotip 0600036",
        "url": "https://devicerts.com/devices/duplotip-0600036",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gasless Tip 601155",
        "url": "https://devicerts.com/devices/gasless-tip-601155",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3659",
        "url": "https://devicerts.com/devices/fibrijet-sa-3659",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3664",
        "url": "https://devicerts.com/devices/fibrijet-sa-3664",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet SA-3610",
        "url": "https://devicerts.com/devices/fibrijet-sa-3610",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Baxter 0601139",
        "url": "https://devicerts.com/devices/baxter-0601139",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3868",
        "url": "https://devicerts.com/devices/fibrijet-sa-3868",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osteoxpress Gd-5515",
        "url": "https://devicerts.com/devices/osteoxpress-gd-5515-e04212db",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duplotip SA376003000000",
        "url": "https://devicerts.com/devices/duplotip-sa376003000000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celling Biosciences GDP Express Kit 0852-0001, CB-5515 and CB-3670",
        "url": "https://devicerts.com/devices/celling-biosciences-gdp-express-kit-0852-0001-cb-5515-an",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Graft Delivery, DePuy Synthes 03-950-001S",
        "url": "https://devicerts.com/devices/graft-delivery-depuy-synthes-03-950-001s",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet AMS700-B",
        "url": "https://devicerts.com/devices/fibrijet-ams700-b",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celling Biosciences GDP Express Kit Component, CB-3670",
        "url": "https://devicerts.com/devices/celling-biosciences-gdp-express-kit-component-cb-3670-cb-3670",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duplotip SA375003000000",
        "url": "https://devicerts.com/devices/duplotip-sa375003000000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "App-100",
        "url": "https://devicerts.com/devices/na-app-100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HC Biologics HC-OPM100",
        "url": "https://devicerts.com/devices/hc-biologics-hc-opm100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet SA-3627",
        "url": "https://devicerts.com/devices/fibrijet-sa-3627",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Nordson Medical MA-1601",
        "url": "https://devicerts.com/devices/nordson-medical-ma-1601",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duplotip 0600038",
        "url": "https://devicerts.com/devices/duplotip-0600038",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet SA-3626",
        "url": "https://devicerts.com/devices/fibrijet-sa-3626",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3768",
        "url": "https://devicerts.com/devices/fibrijet-sa-3768",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fibrijet SA-3657",
        "url": "https://devicerts.com/devices/fibrijet-sa-3657",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Nordson Medical PKG327",
        "url": "https://devicerts.com/devices/nordson-medical-pkg327",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FibriJet SA-3605",
        "url": "https://devicerts.com/devices/fibrijet-sa-3605",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osteoprecision Gd-1115-100",
        "url": "https://devicerts.com/devices/osteoprecision-gd-1115-100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1817-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2016-10-20",
      "product_code": "KGZ",
      "reason": "The sterile packaging may contain small channels in the seal of the pouch,  If the channels are present, the package integrity may be compromised which may affect sterility assurance."
    },
    {
      "number": "Z-0345-2011",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2010-03-15",
      "product_code": "KYZ",
      "reason": "Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection."
    },
    {
      "number": "Z-0346-2011",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2010-03-15",
      "product_code": "KYZ",
      "reason": "Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches potentially resulting in a non-sterile product which may cause transmission of disease or infection."
    },
    {
      "number": "Z-0347-2011",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2010-03-15",
      "product_code": "LFB",
      "reason": "Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection."
    },
    {
      "number": "Z-0348-2011",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2010-03-15",
      "product_code": "ETD",
      "reason": "Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection."
    }
  ]
}