Panels › General, Plastic Surgery › Product code GDY · Class 1
Gauze/Sponge, Internal, X-Ray Detectable
Regulation 878.4450
0510(k)s in 12 months (111 all time)
1recalls in 12 months (66 all time)
53recalls that name a 510(k)
Top companies in GDY
| Company | 510(k)s | Recalls |
|---|---|---|
| American Surgical Company | 0 | 36 |
| Lorrex Health Products | 9 | 0 |
| Argon Medical Devices, Inc | 0 | 7 |
| Medical Perspectives Corp. | 7 | 0 |
| Thantex Specialties, Inc. | 7 | 0 |
| Ultracell Medical Technologies, Inc. | 7 | 0 |
| Mcneil Healthcare, Inc. | 5 | 0 |
| Medical Action Industries, Inc. | 1 | 4 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 5 |
| Carefree Surgical Specialties | 0 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 1997 | K972634 | ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. | GDY |
| Mar 28, 1996 | K960236 | CPR LAP SPONGES Custom Pack Reliability | GDY |
| Feb 22, 1996 | K955599 | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE Stryker Corp. | GDY |
| Dec 19, 1995 | K955322 | PROTEC X-RAY DETECTABLE GAUZE SPONGE Derivados DE Gasa, S.A. DE C.V. | GDY |
| Oct 3, 1995 | K953830 | KENSORB Kentron Health Care, Inc. | GDY |
| Sep 14, 1995 | K953088 | TRIANGULAR SPONGES Medical Perspectives Corp. | GDY |
| Sep 14, 1995 | K953087 | CHERRY PIT DISSECTOR Medical Perspectives Corp. | GDY |
| Sep 14, 1995 | K953062 | CHERRY DISSECTOR Medical Perspectives Corp. | GDY |
| Sep 14, 1995 | K953060 | ROSEBUD DISSECTOR Medical Perspectives Corp. | GDY |
| Sep 14, 1995 | K953059 | KITTNER DISSECTOR Medical Perspectives Corp. | GDY |
| Sep 14, 1995 | K953058 | ROUND STICK SPONGES, FLAT STICK SPONGES Medical Perspectives Corp. | GDY |
| Sep 14, 1995 | K953057 | CYLINDRICAL SPONGE Medical Perspectives Corp. | GDY |
| Jun 21, 1995 | K951911 | GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) Commercial Resources New Mexico, Ltd. | GDY |
| Apr 17, 1995 | K950373 | ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Apr 17, 1995 | K950372 | ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Apr 17, 1995 | K950370 | ULTRACELL ORTHOPEDIC SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Apr 13, 1995 | K950659 | ULTRACELL RETRACTOR COVERS Ultracell Medical Technologies, Inc. | GDY |
| Dec 28, 1994 | K945866 | CYLINDRICAL SPONGE Lorrex Health Products | GDY |
| Dec 28, 1994 | K945606 | TRIANGULAR SPONGES Lorrex Health Products | GDY |
| Dec 28, 1994 | K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES Lorrex Health Products | GDY |
| Dec 28, 1994 | K945335 | CHERRY DISSECTOR Lorrex Health Products | GDY |
| Dec 28, 1994 | K945333 | KITTNER DISSECTOR Lorrex Health Products | GDY |
| Dec 23, 1994 | K944879 | GAUZE SPONGES Clinical Resources, Inc. | GDY |
| Dec 19, 1994 | K940767 | OREX (12X12 X-RAY DETECTABLE) Thantex Specialties, Inc. | GDY |
| Dec 19, 1994 | K940766 | OREX (18X18 X-RAY DETECTABLE) Thantex Specialties, Inc. | GDY |
| Dec 19, 1994 | K940764 | OREX Thantex Specialties, Inc. | GDY |
| Dec 5, 1994 | K945336 | PEANUT DISSECTOR Lorrex Health Products | GDY |
| Dec 5, 1994 | K945334 | CHERRY PIT DISSECTOR Lorrex Health Products | GDY |
| Dec 5, 1994 | K945332 | ROSEBUD DISSECTOR Lorrex Health Products | GDY |
| Jul 26, 1994 | K940436 | SPONGE, LAPAROTOMY, VARIOUS SIZE Shawnee Products, Inc. | GDY |
| May 27, 1994 | K942366 | LORREX GAUZE SPONGES, X-RAY DETECTABLE Lorrex Health Products | GDY |
| May 12, 1994 | K941522 | STERILE X-RAY DETECTABLE GAUZE SPONGES Cush Medical Products | GDY |
| May 12, 1994 | K941344 | LAP SPONGE PRODUCT LINE Cush Medical Products | GDY |
| May 2, 1994 | K940763 | ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) Thantex Specialties, Inc. | GDY |
| May 2, 1994 | K940762 | ISOLYSER (18X18 X-RAY DETECTABLE) Thantex Specialties, Inc. | GDY |
| May 2, 1994 | K940757 | ISOLYSER (4X18) X-RAY DETECTABLE Thantex Specialties, Inc. | GDY |
| May 2, 1994 | K940756 | ISOLYSER (X-RAY DETECTABLE) Thantex Specialties, Inc. | GDY |
| Apr 21, 1994 | K941217 | DUPAQUE SPONGE Dumex Medical Surgical Products, Ltd., CA | GDY |
| Feb 7, 1994 | K934971 | STERILE LAPAROTOMY SPONGES Medsurg Industries, Inc. | GDY |
| Feb 3, 1994 | K935883 | NEUROLOGICAL SPONGES Mcneil Healthcare, Inc. | GDY |
| Feb 2, 1994 | K935993 | SURGICAL SPONGE X-RAY DETECTABLE Mcneil Healthcare, Inc. | GDY |
| Jan 31, 1994 | K935910 | X-RAY PACKING SPONGE Mcneil Healthcare, Inc. | GDY |
| Jan 31, 1994 | K935882 | TONSIL SPONGES Mcneil Healthcare, Inc. | GDY |
| Jan 31, 1994 | K935881 | SPECIALTY SPONGES Mcneil Healthcare, Inc. | GDY |
| Dec 9, 1993 | K932846 | TENCEL X-RAY DETECTABLE SPONGES/LAP PADS Courtaulds Fibers, Inc. | GDY |
| Aug 10, 1992 | K922054 | STERILE GAUZE SPONGES X-RAY DETECTABLE Team Mfg., Inc. | GDY |
| Aug 6, 1992 | K920356 | SURGICAL SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Aug 6, 1992 | K920355 | SPECIALTY SPONGES Ultracell Medical Technologies, Inc. | GDY |
| Aug 6, 1992 | K913303 | LAP SPONGES, MODIFIED Carwild Corp. | GDY |
| Jul 23, 1992 | K913302 | DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED Carwild Corp. | GDY |
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