Generic Medical Device, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Generic Medical Device, Inc. makes
Generic Medical Device, Inc. manufactures surgical tools and materials, including the GMD Universal Circumcision Clamp (Model 200), a device used in pediatric circumcision procedures. The company also produces Universal Surgical Mesh (Model 100) for hernia repair and related reconstructive surgeries, as well as urinary incontinence slings (GMD Universal Urinary Incontinence Sling and GMD Universal Sling, Models 1010 and 1020) for pelvic floor support.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Gmd Universal Circumcision Clamp, Model 200 Ref K063429
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Universal Surgical Mesh, Model 100 Ref K070018
Regimes: 510(k) Registry: 510(k)Gmd Universal Urinary Incontinence Sling Ref K111219
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
2011
- 14 Feb 2011 Z-1390-2011 Unclassified (pre-2012) Terminated Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.
Full distribution text
- 14 Feb 2011 Z-1390-2011 Unclassified (pre-2012) Terminated Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.
2009
- 18 Jun 2009 Z-0268-2010 Unclassified (pre-2012) Terminated Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.
Frequently asked questions
How many devices does Generic Medical Device, Inc. have in the registry?
The registry currently lists 5 devices for Generic Medical Device, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Generic Medical Device, Inc.'s devices?
Among its 5 most recently registered devices, Generic Medical Device, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Generic Medical Device, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Generic Medical Device, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Generic Medical Device, Inc.?
FDA recall records list 2 recalls initiated by Generic Medical Device, Inc., the most recent initiated on 14 Feb 2011. 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 Generic Medical Device, Inc. in the registry?
The most recently registered devices listed for Generic Medical Device, Inc. include GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200, GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012, UNIVERSAL SURGICAL MESH, MODEL 100 and GMD UNIVERSAL URINARY INCONTINENCE SLING.