Panels › General, Plastic Surgery › Product code GDX · Class 1
Scalpel, One-Piece
Regulation 878.4800
0510(k)s in 12 months (26 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in GDX
| Company | 510(k)s | Recalls |
|---|---|---|
| Southmedic, Inc. | 0 | 4 |
| Abco Dealers, Inc. | 1 | 0 |
| Applied Medical Technologies | 1 | 0 |
| Artiberia | 1 | 0 |
| Ascep, Inc. | 1 | 0 |
| Buckman Co., Inc. | 1 | 0 |
| CooperVision, Inc. | 1 | 0 |
| Depuy, Inc. | 1 | 0 |
| Diverse Technologies, Inc. | 1 | 0 |
| Icn Pharmaceuticals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 1992 | K923689 | SURGISTAR BLADES Surgistar, Inc. | GDX |
| Jul 30, 1992 | K921167 | ULTRABLADE Micron Technology, Inc. | GDX |
| Oct 9, 1991 | K914086 | ICAN CYLINDRICAL SPONGES Icn Pharmaceuticals, Inc. | GDX |
| Apr 23, 1991 | K904505 | CCI CORNEAL SCARIFIER Buckman Co., Inc. | GDX |
| Dec 13, 1990 | K905380 | 1-CUT ACL GRAFT KNIFE Depuy, Inc. | GDX |
| Oct 24, 1989 | K895682 | VESSEL LOOPS Applied Medical Technologies | GDX |
| May 26, 1989 | K893033 | MINI-DIAMOND KNIFE L.A.B. Instruments | GDX |
| Jan 29, 1988 | K880028 | OMED DISPOSABLE SCALPEL Oxboro Medical Intl., Inc. | GDX |
| Jun 23, 1987 | K871894 | KCK INDUSTRIES' SURGICAL INSTRUMENTS Kck Industries | GDX |
| Oct 24, 1986 | K863950 | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL Precision Surgical Industries, Inc. | GDX |
| Sep 2, 1986 | K863213 | KEISEI SCALPEL (STERILE AND NON-STERILE) Keisei Medical Industrial Co., Ltd. | GDX |
| Dec 24, 1985 | K854857 | SCALPEL, ONE-PIECE, DISPOSABLE Medelec Intl. Corp. | GDX |
| Aug 6, 1985 | K853103 | MCKNIFE Medical Dimensions | GDX |
| Jun 20, 1985 | K851751 | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 Artiberia | GDX |
| Jan 27, 1984 | K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 Imm Enterprises , Ltd. | GDX |
| Jan 27, 1984 | K833467 | SURE-CUT Diverse Technologies, Inc. | GDX |
| Apr 12, 1983 | K830745 | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL Lab Industries, Inc. | GDX |
| Oct 22, 1982 | K822893 | G.E.V. DISPOSABLE SCALPELS Ascep, Inc. | GDX |
| Oct 6, 1982 | K822749 | PILLING DIAMOND KNIFE Narco Scientific | GDX |
| May 5, 1982 | K820869 | DISPOSABLE #11 SCALPEL BLADE W/SHORT Van-Tec, Inc. | GDX |
| Apr 9, 1982 | K820730 | MICRO CISE DIAMOND SCALPEL CooperVision, Inc., GB | GDX |
| Jan 5, 1982 | K813422 | SCALPEL Abco Dealers, Inc. | GDX |
| Jul 20, 1981 | K811707 | AXICUT DISPOSABLE SCALPEL Neonatal Corp. | GDX |
| Feb 11, 1980 | K800177 | I.M. BLADES Instrument Makar, Inc. | GDX |
| Feb 13, 1979 | K790259 | STERILE DISPOSABLE KNIFE Intermedics, Inc. | GDX |
| Jul 27, 1978 | K780998 | SCALPEL Isolab, Inc. | GDX |
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