Panels › General, Plastic Surgery › Product code KIJ · Class 1
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Regulation 878.4820
0510(k)s in 12 months (29 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in KIJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 10 |
| Black & Decker(Tm) | 5 | 0 |
| Dyonics, Inc. | 3 | 0 |
| Aeg Power Tool Corp. | 2 | 0 |
| Jeil Medical Corporation | 2 | 0 |
| 3M Health Care, Ltd. | 1 | 0 |
| Acu Med, Inc. | 1 | 0 |
| Arthrex, Inc. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Bowen & Company, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 27, 2016 | K163308 | SMARTO Jeil Medical Corporation, KR | KIJ |
| Nov 6, 2012 | K112599 | INSURGICAL SINGLE USE POWER EQUIPMENT Insurgical, LLC | KIJ |
| Dec 17, 2010 | K101563 | SMARTO Jeil Medical Corporation, KR | KIJ |
| Sep 4, 1997 | K972367 | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT Stryker Instruments | KIJ |
| Apr 30, 1997 | K970378 | STRYKER 2115 REPLACEMENT BATTERY (2115) Implant Resource, Inc. | KIJ |
| May 7, 1996 | K960711 | ACUMED BONE GRAFT SYSTEM Acu Med, Inc. | KIJ |
| May 17, 1995 | K951450 | SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY Strenumed, Inc. | KIJ |
| Mar 2, 1995 | K944488 | S & S ORTHOPEDIC WIRE DRIVER 701 S & S Orthopedic , Ltd. | KIJ |
| Nov 14, 1994 | K941285 | ARTHREX GRAFT HARVESTING KIT Arthrex, Inc. | KIJ |
| Nov 7, 1994 | K933101 | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES Osteomed Corp. | KIJ |
| Apr 5, 1994 | K933337 | R AND D BATTERY REPLACEMENT R & D Batteries, Inc. | KIJ |
| Jan 28, 1994 | K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM Micro Surgical Instruments Corp. | KIJ |
| Jan 7, 1994 | K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM 3M Health Care, Ltd. | KIJ |
| Dec 7, 1988 | K884839 | MODIFIED SAW BLADES TO THE SAGITAL SAW Dyonics, Inc. | KIJ |
| Nov 14, 1988 | K873766 | STERNAL POWER AWL Bowen & Company, Inc. | KIJ |
| Nov 7, 1986 | K864137 | LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III Bio-Rad | KIJ |
| Jun 28, 1985 | K850789 | FLUTED SUCTION MENISCAL CUTTER T. Korossurgical Instruments Corp. | KIJ |
| Mar 11, 1985 | K844163 | EZ 502 Aeg Power Tool Corp. | KIJ |
| Mar 11, 1985 | K844162 | EZ 505 Aeg Power Tool Corp. | KIJ |
| Oct 22, 1982 | K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE Xomed, Inc. | KIJ |
| May 7, 1982 | K820367 | INTRA-ARTICULAR SURGICAL SYSTEM Dyonics, Inc. | KIJ |
| Mar 19, 1980 | K800315 | DUAL MPC CHARGER Black & Decker(Tm) | KIJ |
| Mar 19, 1980 | K800314 | POWER PACK Black & Decker(Tm) | KIJ |
| Feb 22, 1980 | K800313 | SAGITTAL SAW Black & Decker(Tm) | KIJ |
| Feb 22, 1980 | K800312 | 150 DRIVER/REAMER Black & Decker(Tm) | KIJ |
| Feb 22, 1980 | K800311 | 450 DRILL/800 DRILL Black & Decker(Tm) | KIJ |
| Feb 5, 1979 | K790063 | DRILL, CORDLESS SURGICAL Richard'S Medical Equip., Inc. | KIJ |
| May 3, 1978 | K780645 | HMD-2000 BATTERY-POWERED MINI-DRILL, THE Medishield, Inc. | KIJ |
| Feb 1, 1978 | K771218 | INTRA-ARTICULAR SHAVER Dyonics, Inc. | KIJ |
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