Panels › General, Plastic Surgery › Product code GES · Class 1
Blade, Scalpel
Regulation 878.4800
0510(k)s in 12 months (48 all time)
0recalls in 12 months (13 all time)
1recalls that name a 510(k)
Top companies in GES
| Company | 510(k)s | Recalls |
|---|---|---|
| Aeroceuticals | 4 | 0 |
| Becton Dickinson & Company | 0 | 4 |
| Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | 0 | 4 |
| Imm Enterprises , Ltd. | 3 | 0 |
| Medelec Intl. Corp. | 3 | 0 |
| American Safety Razor Co. | 2 | 0 |
| Keisei Medical Industrial Co., Ltd. | 2 | 0 |
| Lukens Corp. | 2 | 0 |
| Miltex, Inc. | 0 | 2 |
| Vxtra Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2003 | K032242 | PERSONNA PLUS SAFETY SCALPEL SYSTEM Omi Manufacturing Pty., Ltd. | GES |
| Aug 18, 1993 | K932998 | EASY-ON Devon Industries, Inc. | GES |
| Feb 18, 1993 | K923170 | LOS ALAMOS RETRACTABLE KNIFE Innovative Surgical Technology, Inc. | GES |
| May 5, 1992 | K915119 | SCALPEL BLADE REMOVER (BLADEGARD) Intergrated Visual, Inc. | GES |
| May 13, 1991 | K911913 | PRECISION GLIDE - ENHANCED SURGICAL BLADE Bd Becton Dickinson Vacutainer Systems Preanalytic | GES |
| Mar 1, 1990 | K900266 | STERILE CARBON STEEL SURGICAL BLADE Rahn Laboratories | GES |
| Dec 27, 1988 | K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE Anchor Products Co. | GES |
| Jun 15, 1988 | K881638 | SURGICAL BLADE Far East Intl. Trading Corp. | GES |
| Feb 10, 1988 | K880244 | SURGICAL BLADES Ailee C/O Havel'S, Inc. | GES |
| Sep 24, 1987 | K873493 | NINJA SCALPEL Primrose Medical, Inc. | GES |
| Sep 4, 1987 | K873142 | PERSONNA DISPOSABLE SCALPEL American Safety Razor Co. | GES |
| Oct 24, 1986 | K863885 | SABLE BLADES Sable Industries | GES |
| Oct 24, 1986 | K863867 | DEXTRA DISPOSABLE BLADES Storz Instrument Co. | GES |
| Sep 2, 1986 | K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) Keisei Medical Industrial Co., Ltd. | GES |
| Sep 2, 1986 | K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) Keisei Medical Industrial Co., Ltd. | GES |
| Jan 24, 1986 | K855104 | ANGIOMED SKIN FASCIA KNIFE Angiomed U.S., Inc. | GES |
| Dec 24, 1985 | K854860 | BLADES, SCALPEL CARBON STEET Medelec Intl. Corp. | GES |
| Dec 24, 1985 | K854859 | BLADES, SCALPEL STAINLESS STEEL Medelec Intl. Corp. | GES |
| Dec 17, 1985 | K854620 | SURGICAL BLADES Niraj Industries | GES |
| Dec 2, 1985 | K854561 | BLADE, SCALPEL Medelec Intl. Corp. | GES |
| Sep 24, 1985 | K853528 | STAINLESS STEEL & CARBON STEEL STERILE BLADES Abco Dealers, Inc. | GES |
| Jul 11, 1985 | K852661 | APOLLO STERILE BLADES Orthofab, Inc. | GES |
| Jun 13, 1985 | K852141 | STERILE SURGICAL BLADES Miltex Instrument Co. | GES |
| Apr 25, 1985 | K851157 | SURGIMED - SURGICAL BLADES Surgimed Corp. | GES |
| Jan 18, 1985 | K844759 | SURGICAL SCALPEL BLADES & DISPOSABLES Cross Country Paper Products Corp. | GES |
| Nov 8, 1984 | K844001 | LANCE BLADES & SCALPELS Perry, Div. | GES |
| Jun 5, 1984 | K841883 | SURGEON'S BLADES STERILE BLADE An-Med Intl. | GES |
| Apr 24, 1984 | K841320 | PERCUTANEOUS TRIG. FINGER RELEASE KNIFE Anapach Effort, Inc. | GES |
| Mar 12, 1984 | K834514 | FASCIA CUTTER Stryker Corp. | GES |
| Jan 27, 1984 | K834195 | JAKOBI SURG. INSTRUMENTS #11 11/13/14 Imm Enterprises , Ltd. | GES |
| Jan 27, 1984 | K834194 | JAKOBI SURG. INSTRUMENTS #1 19/10/26 Imm Enterprises , Ltd. | GES |
| Jan 27, 1984 | K834182 | H.R. JAKOBI SURG. INSTRUMENTS #11 27/37 Imm Enterprises , Ltd. | GES |
| Jul 2, 1982 | K821737 | DISP. MICROSURGICAL KNIVES Coburn Optical Ind., Inc. | GES |
| Oct 2, 1981 | K812516 | SURGICAL BLADES & SCAPELS (SMPL. W/510K) Needle Industries(Usa), Inc. | GES |
| Sep 16, 1981 | K812526 | MICRO BLADE II Vxtra Corp. | GES |
| Aug 31, 1981 | K812160 | MICROSURGICAL BLADE Vxtra Corp. | GES |
| Aug 31, 1981 | K812071 | RK IV SURGICAL BLADES Santa Barbara Medco, Inc. | GES |
| Mar 20, 1981 | K810572 | BLADE, HANDLE, SCALPEL FORCEPS, SURGERY Technical Resources, Inc. | GES |
| Oct 24, 1978 | K781716 | BLADE, 20 ANGLE/MICRO BLADE HOLDER Edward Weck, Inc. | GES |
| Jun 22, 1977 | K771045 | BLADES, SCALPEL American Safety Razor Co. | GES |
| May 6, 1977 | K770800 | HANDLES, BLADE, SURGICAL Lukens Corp. | GES |
| May 6, 1977 | K770798 | BLADES, SURGICAL, STERILE Lukens Corp. | GES |
| Mar 30, 1977 | K770217 | LANCE LTD. STERI. STITCH CUTTER BLADE Aeroceuticals | GES |
| Jan 6, 1977 | K761322 | SURGICAL BLADES Richard-Allan Medical Ind., Inc. | GES |
| Oct 5, 1976 | K760605 | LIGHTCAST II CARBIDE BLADE Merck, Sharp & Dohme | GES |
| Sep 13, 1976 | K760364 | HANDLE, SCALPEL, STAINLESS STEEL Aeroceuticals | GES |
| Sep 13, 1976 | K760363 | SCALPEL, SURGICAL, STERILE STAINLESS Aeroceuticals | GES |
| Sep 13, 1976 | K760361 | BLADE, SURGICAL SCALPEL, STERILE Aeroceuticals | GES |
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