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Sanarus Medical, Inc.

United StatesFDA applicant, unverified

Devices
14
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue14

Newest first, rows 1-14 of 14

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Rows 1-14 of 14

FDA recalls2

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

  • 2003

    • 16 Jun 2003 Z-1008-03 Unclassified (pre-2012) Terminated Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure. Distribution: Product was released for distribution to 12 consignees across the United States, including US states: GA, WI, TX and NY.…
      Full distribution text Product was released for distribution to 12 consignees across the United States, including US states: GA, WI, TX and NY. A total of 41 units from the lot had been shipped to these consignees. The recall was extended to the user level who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
      Submission number: K022314
    • 13 May 2003 Z-0935-03 Unclassified (pre-2012) Terminated Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure. Distribution: Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S.…
      Full distribution text Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S. States include: MD, TN, TX, OH, and IL. The recall was appropriately extended to the user level; i.e., clinics, hospitals and medical centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
      Submission number: K022879

Frequently asked questions

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

The registry currently lists 14 devices for Sanarus Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sanarus Medical, Inc.'s devices?

Among its 14 most recently registered devices, Sanarus Medical, Inc. has devices listed in FDA 510(k) (14 devices).

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

Among its 14 most recently registered devices, the classes recorded for Sanarus Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sanarus Medical, Inc.?

FDA recall records list 2 recalls initiated by Sanarus Medical, Inc., the most recent initiated on 16 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 Sanarus Medical, Inc. in the registry?

The most recently registered devices listed for Sanarus Medical, Inc. include MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM, MODELS VS2000, V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600, SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM and SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM.

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