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Carbomedics, Inc.

United StatesFDA applicant, unverified

Devices
23
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Carbomedics, Inc. makes

Carbomedics, Inc. manufactures medical devices including pressure transducers for monitoring physiological measurements, dental implants coated with pyrolite carbon or hydroxylapatite for osseointegration, and acetabular and femoral components for hip prostheses. The company also produces valve sizers for cardiac applications and an annulofloor system for mitral valve procedures.

The portfolio includes devices regulated as Class I, Class II, and Class III under FDA guidelines, with submissions recorded via 510(k) clearances and Premarket Approval Applications (PMA). These products are listed in the FDA’s regulatory databases and are based in the United States.

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

Catalogue23

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Rows 1-23 of 23

FDA recalls1

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

FDA recall records list 1 recall initiated by Carbomedics, Inc., initiated on 2002-04-30. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and mechanical integrity. 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.

  • 2002

    • 30 Apr 2002 Z-0738-04 Unclassified (pre-2012) Terminated Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use. Distribution: US nationwide and to the following foreign countries: Denmark, Ireland, China, Cyprus, Greece, France, UK, Protugal,…
      Full distribution text US nationwide and to the following foreign countries: Denmark, Ireland, China, Cyprus, Greece, France, UK, Protugal, Ecuador, India, Japan, Hong Kong, Italy, Sweden, Belgium, Norway, Argentina, Spain, Malta, Austria, Switzerland, Netherlands, Germany, Australia, Finland
      Submission number: K960169

Frequently asked questions

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

The registry currently lists 23 devices for Carbomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Carbomedics, Inc.'s devices?

Among its 23 most recently registered devices, Carbomedics, Inc. has devices listed in FDA 510(k) (22 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

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

Among its 23 most recently registered devices, the classes recorded for Carbomedics, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Carbomedics, Inc.?

FDA recall records list 1 recall initiated by Carbomedics, Inc., the most recent initiated on 30 Apr 2002. 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 Carbomedics, Inc. in the registry?

The most recently registered devices listed for Carbomedics, Inc. include MINATURE PRESSURE TRANSDUCER, HYDROXYLAPATITE ALVEOLAR RIDGE MAIN, VALVE SIZER and PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT.

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