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Endocare, Inc.

United StatesFDA applicant, unverified

Endocare, Inc. is a medical device manufacturer, with 22 devices listed in FDA 510(k) (FDA Class II) and 1 FDA recall as of 14 Nov 2026.

Devices
22
FDA recalls
1

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA 510(k) 22
Device classes
  • FDA Class II 22
FDA recalls
Identifiers
  • DUNS 928955509

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Endocare, Inc. makes

EndoCare, Inc. manufactures cryosurgical systems and microwave ablation devices, including cryogen-powered surgical sets, microwave ablation generators, and disposable probes and antenna kits for targeted tissue ablation. Products like the PerCryo™ system and MicroThermX Microwave Ablation System are designed for controlled tissue freezing or heating in medical procedures. Additional accessories, such as the V-Probe™ and SynchroWave Antenna Kit, support precision treatment delivery in various clinical applications.

The company’s portfolio is classified under FDA’s Class II medical devices, with regulatory submissions recorded in the FDA’s 510(k) and UDIs (Unique Device Identifiers) registries. These devices are intended for use in the United States, where EndoCare, Inc. is based.

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

Catalogue22

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Rows 1-22 of 22

Company details

DUNS number
928955509
Phone
5123282892

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by ENDOCARE, INC., initiated on 2002-10-25. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. 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

    • 25 Oct 2002 Z-0728-03 Unclassified (pre-2012) Terminated Device design failure, connectivity. Distribution: Product was sent only to one Canadian distribution company whoin turn sold it internationally and back to the USA.

Frequently asked questions

How many devices does ENDOCARE, INC. have in the registry?

The registry currently lists 22 devices for ENDOCARE, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ENDOCARE, INC.'s devices?

Among its 22 most recently registered devices, ENDOCARE, INC. has devices listed in FDA 510(k) (22 devices).

What risk classes do ENDOCARE, INC.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for ENDOCARE, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for ENDOCARE, INC.?

FDA recall records list 1 recall initiated by ENDOCARE, INC., the most recent initiated on 25 Oct 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 ENDOCARE, INC. in the registry?

The most recently registered devices listed for ENDOCARE, INC. include CRYOCARE CARDIAC SURGICAL SYSTEM, ENDOCARE CRYCARE CRYOSURGICAL SYSTEM, SANARUS CORE TISSUE BIOPSY SYSTEM and ENDOCARE ELECTORNIC THERMOMETER SYSTEM.

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