Instrument, Microsurgical
Regulation 882.4525
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GZX
| Company | 510(k)s | Recalls |
|---|---|---|
| Keeler Instruments, Inc. | 4 | 0 |
| Downs Surgical , Ltd. | 2 | 0 |
| American Russian Medical Services, Inc. | 1 | 0 |
| American V. Mueller | 1 | 0 |
| Clarus Medical Systems, Inc. | 1 | 0 |
| Cordis Corp. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| Medtronic Xomed, Inc. | 0 | 1 |
| O.R. Specialties, Inc. | 1 | 0 |
| Prothia USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 20, 1993 | K932169 | MICROSURGICAL INSTRUMENTS American Russian Medical Services, Inc. | GZX |
| Apr 7, 1993 | K926048 | CLARUS ENDOSCOPIC BALL PROBE Clarus Medical Systems, Inc. | GZX |
| Aug 26, 1991 | K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK O.R. Specialties, Inc. | GZX |
| Feb 16, 1989 | K890216 | MICROSURGICAL KERATOME Kinetic Medical Products | GZX |
| Dec 17, 1987 | K873934 | RANGE OF CROCODILE ACTION INSTRUMENTS Downs Surgical , Ltd., GB | GZX |
| Dec 17, 1987 | K873933 | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM Downs Surgical , Ltd. | GZX |
| Aug 25, 1986 | K862971 | MICRA MICROSURGICAL INSTRUMENTS Cordis Corp. | GZX |
| Nov 7, 1985 | K853179 | VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND Keeler Instruments, Inc. | GZX |
| Nov 7, 1985 | K853161 | THE VICKERS STANDARD MICROSURGERY SET Keeler Instruments, Inc. | GZX |
| Oct 28, 1985 | K853181 | VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED Keeler Instruments, Inc. | GZX |
| Oct 28, 1985 | K853180 | VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED Keeler Instruments, Inc. | GZX |
| Jun 8, 1983 | K831071 | UNIVERSAL INSTRU. SET FOR NEUROVASCULAR Prothia USA, Inc. | GZX |
| Feb 27, 1981 | K810485 | DUJOVNY MICROSURGICAL SCISSORS American V. Mueller | GZX |
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