Power Medical Interventions, Inc.
United StatesFDA applicant, unverified
- Devices
- 22
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Power Medical Interventions, Inc. makes
The company manufactures surgical stapling devices, including circular and linear staplers with digital loading units, reload cartridges, and vascular-specific models. Products also include intelligent power units, consoles, delivery systems, and articulating endoscopic linear cutters designed for precise tissue approximation and division in minimally invasive and open surgical procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements.
Catalogue
Search and filter all 22 devicesFDA recalls
FDA recall records list 5 recalls initiated by Power Medical Interventions, Inc., the earliest on 2003-06-30 and the most recent on 2007-05-12. By recorded status: 5 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.
2007
- 12 May 2007 Z-1099-2007 Unclassified (pre-2012) Terminated Malfunction - improper staple formation
2003
- 20 Nov 2003 Z-0252-04 Unclassified (pre-2012) Terminated improper staple formation or anvil jam
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- 20 Nov 2003 Z-0253-04 Unclassified (pre-2012) Terminated improper staple formation or anvil jam
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- 30 Jun 2003 Z-1048-03 Unclassified (pre-2012) Terminated latching mechanism failure
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- 30 Jun 2003 Z-1049-03 Unclassified (pre-2012) Terminated latching mechanism failure
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- 20 Nov 2003 Z-0252-04 Unclassified (pre-2012) Terminated improper staple formation or anvil jam
Frequently asked questions
How many devices does Power Medical Interventions, Inc. have in the registry?
The registry currently lists 22 devices for Power Medical Interventions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Power Medical Interventions, Inc.'s devices?
Among its 22 most recently registered devices, Power Medical Interventions, Inc. has devices listed in FDA 510(k) (22 devices).
What risk classes do Power Medical Interventions, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Power Medical Interventions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Power Medical Interventions, Inc.?
FDA recall records list 5 recalls initiated by Power Medical Interventions, Inc., the most recent initiated on 12 May 2007. 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 Power Medical Interventions, Inc. in the registry?
The most recently registered devices listed for Power Medical Interventions, Inc. include IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS, POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH, SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS and SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS.