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Medamicus, Inc.

United StatesFDA applicant, unverified

Devices
20
FDA recalls
7

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Medamicus, Inc. makes

Medamicus, Inc. manufactures medical devices including peelable introducers, valved peelable introducers, percutaneous introducers, pressure transducer catheter tips, and introducer sets, which are used for vascular access and medical procedures.

The company's devices are classified as Class II and listed in the FDA 510(k) registry. Medamicus is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

Newest first, rows 1-20 of 20

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Rows 1-20 of 20

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 7 recalls initiated by Medamicus, Inc., initiated on 2003-06-06. By recorded status: 7 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2003

    • 6 Jun 2003 Z-0962-03 Unclassified (pre-2012) Terminated Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was…
      Full distribution text The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
      Submission number: K021044
    • 6 Jun 2003 Z-0963-03 Unclassified (pre-2012) Terminated Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was…
      Full distribution text The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
      Submission number: K021044
    • 6 Jun 2003 Z-0964-03 Unclassified (pre-2012) Terminated Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was…
      Full distribution text The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
      Submission number: K021044
    • 6 Jun 2003 Z-0965-03 Unclassified (pre-2012) Terminated Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was…
      Full distribution text The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
      Submission number: K021044
    • 6 Jun 2003 Z-0966-03 Unclassified (pre-2012) Terminated Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was…
      Full distribution text The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
      Submission number: K021044
    • 6 Jun 2003 Z-0967-03 Unclassified (pre-2012) Terminated Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was…
      Full distribution text The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
      Submission number: K021044
    • 6 Jun 2003 Z-0968-03 Unclassified (pre-2012) Terminated Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. Distribution: The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was…
      Full distribution text The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.
      Submission number: K021044

Frequently asked questions

How many devices does Medamicus, Inc. have in the registry?

The registry currently lists 20 devices for Medamicus, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medamicus, Inc.'s devices?

Among its 20 most recently registered devices, Medamicus, Inc. has devices listed in FDA 510(k) (20 devices).

What risk classes do Medamicus, Inc.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Medamicus, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Medamicus, Inc.?

FDA recall records list 7 recalls initiated by Medamicus, Inc., the most recent initiated on 6 Jun 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Medamicus, Inc. in the registry?

The most recently registered devices listed for Medamicus, Inc. include MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER, VALVED PEELABLE INTRODUCER, LUMAX(MODIFICATION) and INTRODUCER, PERCUTANEOUS -- MODIFICATION.

Generated automatically from registry data and not verified by a human reviewer.