Generic Medical Devices, Inc.
Ocean Shores, WA, US
Generic Medical Devices, Inc. appears in FDA device records in Ocean Shores, WA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Generic Medical Devices, Inc. in 2010.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1390-2011 | The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck. | Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs. | Terminated | ||
| Z-0268-2010 | GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. | Product that is approved only for use outside the U.S. was shipped to two customers in the U.S. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain