{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Surmodics, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/surmodics-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/surmodics-inc",
    "json_url": "https://devicerts.com/manufacturers/surmodics-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/surmodics-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA PMA",
        "url": "https://open.fda.gov/apis/device/pma/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": null,
    "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/surmodics-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": "Surmodics, Inc.",
    "url": "https://devicerts.com/manufacturers/surmodics-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "3014687026"
      },
      {
        "label": "DUNS",
        "value": "098414659"
      }
    ],
    "summary": "Surmodics, Inc. is a medical device manufacturer, with 64 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II and III) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 64,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "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": 52
      },
      {
        "registry": "FDA 510(k)",
        "devices": 11
      },
      {
        "registry": "FDA PMA",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 41
      },
      {
        "class": "FDA Class III",
        "devices": 23
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 64,
    "all_devices_url": "https://devicerts.com/manufacturers/surmodics-inc",
    "items": [
      {
        "name": "Pounce Sheath PFS-0035-16F14",
        "url": "https://devicerts.com/devices/pounce-sheath-pfs-0035-16f14",
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        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 018, 200cm, Angle SRA-MC18-ANG200",
        "url": "https://devicerts.com/devices/sublime-microcatheter-018-200cm-angle-sra-mc18-ang200",
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        "status": "Active",
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        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 014, 150cm, Angle SRA-MC14-ANG150",
        "url": "https://devicerts.com/devices/sublime-microcatheter-014-150cm-angle-sra-mc14-ang150",
        "model_reference": null,
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        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pounce ™ XL Thrombectomy PTS-1011-7F135",
        "url": "https://devicerts.com/devices/pounce-xl-thrombectomy-pts-1011-7f135",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 014, 65cm, Angle SRA-MC14-ANG065",
        "url": "https://devicerts.com/devices/sublime-microcatheter-014-65cm-angle-sra-mc14-ang065",
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        ],
        "status": "Active",
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        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513506012",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513506012",
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        ],
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        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 018, 150cm, Angle SRA-MC18-ANG150",
        "url": "https://devicerts.com/devices/sublime-microcatheter-018-150cm-angle-sra-mc18-ang150",
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        ],
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      },
      {
        "name": "Sublime Microcatheter, 018, 150cm, Straight SRA-MC18-STR150",
        "url": "https://devicerts.com/devices/sublime-microcatheter-018-150cm-straight-sra-mc18-str150",
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        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 035, 150cm, Angle SRA-MC35-ANG150",
        "url": "https://devicerts.com/devices/sublime-microcatheter-035-150cm-angle-sra-mc35-ang150",
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      },
      {
        "name": "SurVeil DCB SRV03513505012",
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        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513504012",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513504012",
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        "status": "Active",
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        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 018, 65cm, Angle SRA-MC18-ANG065",
        "url": "https://devicerts.com/devices/sublime-microcatheter-018-65cm-angle-sra-mc18-ang065",
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      },
      {
        "name": "SurVeil DCB SRV03513506080",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513506080",
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        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513507080",
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 035, 200cm, Straight SRA-MC35-STR200",
        "url": "https://devicerts.com/devices/sublime-microcatheter-035-200cm-straight-sra-mc35-str200",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513504060",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513504060",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pounce ™ Thrombectomy PTS-0607-7F135",
        "url": "https://devicerts.com/devices/pounce-thrombectomy-pts-0607-7f135-85ec1d94",
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        "device_class": "Class II",
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        "status": "Active",
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        "open_recall": false
      },
      {
        "name": "Pounce™ Thrombectomy System PTS-0607-7F135",
        "url": "https://devicerts.com/devices/pounce-thrombectomy-system-pts-0607-7f135",
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        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513505040",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513505040",
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        "device_class": "Class III",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 014, 200cm, Straight SRA-MC14-STR200",
        "url": "https://devicerts.com/devices/sublime-microcatheter-014-200cm-straight-sra-mc14-str200",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513505060",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513505060",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 035, 150cm, Straight SRA-MC35-STR150",
        "url": "https://devicerts.com/devices/sublime-microcatheter-035-150cm-straight-sra-mc35-str150",
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        "device_class": "Class II",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 035, 135cm, Angle SRA-MC35-ANG135",
        "url": "https://devicerts.com/devices/sublime-microcatheter-035-135cm-angle-sra-mc35-ang135",
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        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513506015",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513506015",
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        "device_class": "Class III",
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          "GUDID"
        ],
        "status": "Active",
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        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513506040",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513506040",
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        "device_class": "Class III",
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        "status": "Active",
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        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513506010",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513506010",
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        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pounce Venous Thrombectomy System VTS-0018-09010",
        "url": "https://devicerts.com/devices/pounce-venous-thrombectomy-system-vts-0018-09010-f2df7707",
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        "device_class": "Class II",
        "registries": [
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        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 018, 65cm, Straight SRA-MC18-STR065",
        "url": "https://devicerts.com/devices/sublime-microcatheter-018-65cm-straight-sra-mc18-str065",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 014, 65cm, Straight SRA-MC14-STR065",
        "url": "https://devicerts.com/devices/sublime-microcatheter-014-65cm-straight-sra-mc14-str065",
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        "device_class": "Class II",
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        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 035, 90cm, Angle SRA-MC35-ANG090",
        "url": "https://devicerts.com/devices/sublime-microcatheter-035-90cm-angle-sra-mc35-ang090",
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513506060",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513506060",
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        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 014, 150cm, Straight SRA-MC14-STR150",
        "url": "https://devicerts.com/devices/sublime-microcatheter-014-150cm-straight-sra-mc14-str150",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
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        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 018, 200cm, Straight SRA-MC18-STR200",
        "url": "https://devicerts.com/devices/sublime-microcatheter-018-200cm-straight-sra-mc18-str200",
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        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513507040",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513507040",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pounce™ Venous Thrombectomy System VTS-1018-09010",
        "url": "https://devicerts.com/devices/pounce-venous-thrombectomy-system-vts-1018-09010",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513505015",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513505015",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513505080",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513505080",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513505010",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513505010",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513507010",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513507010",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 035, 90cm, Straight SRA-MC35-STR090",
        "url": "https://devicerts.com/devices/sublime-microcatheter-035-90cm-straight-sra-mc35-str090",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513504010",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513504010",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513504015",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513504015",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sublime Microcatheter, 014, 200cm, Angle SRA-MC14-ANG200",
        "url": "https://devicerts.com/devices/sublime-microcatheter-014-200cm-angle-sra-mc14-ang200",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pounce Sheath PFS-0035-12F14",
        "url": "https://devicerts.com/devices/pounce-sheath-pfs-0035-12f14",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513507060",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513507060",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pounce™ Venous Thrombectomy System VTS-0018-09010",
        "url": "https://devicerts.com/devices/pounce-venous-thrombectomy-system-vts-0018-09010",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513504040",
        "url": "https://devicerts.com/devices/surveil-dcb-srv03513504040",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurVeil DCB SRV03513504080",
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