Panels › General, Plastic Surgery › Product code HSZ · Class 1
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Regulation 878.4820
0510(k)s in 12 months (56 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in HSZ
| Company | 510(k)s | Recalls |
|---|---|---|
| The Anspach Effort, Inc. | 4 | 4 |
| Micro-Aire Surgical Instruments, Inc. | 8 | 0 |
| American Sterilizer Co. | 3 | 0 |
| Micro Surgical Instruments Corp. | 3 | 0 |
| Tava Surgical Instruments | 3 | 0 |
| Acufex Microsurgical, Inc. | 2 | 0 |
| Anspach Mfg., Inc. | 2 | 0 |
| De Soutter Medical, Ltd. | 2 | 0 |
| Romano Surgical Instrumentation, Inc. | 2 | 0 |
| Smith & Nephew Richards, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 21, 1999 | K991588 | EMS SWISS ORTHOCLAST (Ems Sa) Electro Medical Systems | HSZ |
| Oct 31, 1997 | K972860 | CURVTEK TSR SYSTEM Biolectron, Inc. | HSZ |
| Apr 29, 1997 | K970345 | ALIGNMENT INSTRUMENT Richard Wolf Medical Instruments Corp. | HSZ |
| Jan 17, 1996 | K955084 | ASPACH 65,000 (MODIFICATION) The Anspach Effort, Inc. | HSZ |
| Oct 16, 1995 | K954080 | SODEM HIGH SPEED SYSTEM Sodem Diffusion SA | HSZ |
| May 11, 1995 | K944590 | ETHICON DRILL BIT AND DRILL GUIDE ETHICON, Inc. | HSZ |
| Mar 10, 1995 | K934336 | SPINALPLANE Synvasive Technology, Inc. | HSZ |
| Nov 16, 1994 | K940276 | FILTER, DIFFUSER Anspach Mfg., Inc. | HSZ |
| Sep 6, 1994 | K942760 | PNEUMATIC WIRE TENSIONER Smith & Nephew Richards, Inc. | HSZ |
| Aug 25, 1994 | K941681 | ARTHREX CIRCULAR HARVESTING SAW Arthrex, Inc. | HSZ |
| Apr 21, 1994 | K935367 | TAVA WIRE-DRIVER Tava Surgical Instruments | HSZ |
| Jan 27, 1994 | K934431 | PNEUMATIC WIRE TENSIONER Smith & Nephew Richards, Inc. | HSZ |
| Oct 27, 1993 | K930785 | THE DE SOUTTER M182 DRILL De Soutter Medical, Ltd., GB | HSZ |
| Oct 27, 1993 | K930784 | THE DE SOUTTER M193 REAMER De Soutter Medical, Ltd., GB | HSZ |
| Jul 22, 1993 | K926547 | MEDNEXT 1000 BONE DISSECTING SYSTEM Mednext, Inc. | HSZ |
| Sep 18, 1992 | K922661 | HHI PNEUMATIC ROTARY DRILL H&H Instruments | HSZ |
| Feb 5, 1992 | K915139 | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE Micro Surgical Instruments Corp. | HSZ |
| Jan 13, 1992 | K914845 | M170 PNEUMATICALLY OPERATED OSCILLATING SAW Desutter Medical , Ltd., GB | HSZ |
| Nov 13, 1991 | K913629 | JOHNSON AND JOHNSON POWER SYSTEM Johnson & Johnson Orthopaedics, Inc. | HSZ |
| Nov 7, 1991 | K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR Osteo AG | HSZ |
| Feb 5, 1991 | K905027 | CUP OUT Anspach Mfg., Inc. | HSZ |
| Jan 8, 1991 | K905277 | MICRO-AIRE 4220-000 OSCILLATING SAW Micro Surgical Instruments Corp. | HSZ |
| Dec 19, 1990 | K905187 | BONE RASPS Micro Surgical Instruments Corp. | HSZ |
| Nov 26, 1990 | K904949 | A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS Micro-Aire Surgical Instruments, Inc. | HSZ |
| Sep 14, 1990 | K903713 | OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 Micro-Aire Surgical Instruments, Inc. | HSZ |
| May 14, 1990 | K901455 | THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM Kirschner Medical Corp. | HSZ |
| Feb 2, 1990 | K900210 | BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 Micro-Aire Surgical Instruments, Inc. | HSZ |
| Sep 29, 1989 | K885229 | MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS Romano Surgical Instrumentation, Inc. | HSZ |
| Sep 11, 1989 | K895121 | INTERMEDICS POWER BROACH IMPACTOR Intermedics Orthopedics | HSZ |
| Jan 30, 1989 | K885273 | MICRO SURGICAL INSTRUMENT SYSTEM Tava Surgical Instruments | HSZ |
| Nov 16, 1988 | K884492 | MICRO SURGICAL INSTRUMENT SYSTEM Tava Surgical Instruments | HSZ |
| Nov 9, 1988 | K881954 | CONCEPT POWER SYSTEM Concept, Inc. | HSZ |
| May 4, 1988 | K880881 | ARTUS DISPOSABLE SHEATHS/CUTTERS Acufex Microsurgical, Inc. | HSZ |
| Apr 15, 1988 | K881250 | ACE PNEUMATIC OSCILLATING SAW Buckman Co., Inc. | HSZ |
| Mar 25, 1988 | K880074 | RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS Romano Surgical Instrumentation, Inc. | HSZ |
| Feb 17, 1988 | K880324 | MICRO-AIRE CEMENT REMOVAL TOOLS Micro-Aire Surgical Instruments, Inc. | HSZ |
| Jul 21, 1987 | K872550 | 1.1 COUPLERS AND 1.2 ADAPTERS Micro-Aire Surgical Instruments, Inc. | HSZ |
| Jun 5, 1987 | K871891 | KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER KARL STORZ Endoscopy-America, Inc. | HSZ |
| Apr 15, 1987 | K871287 | ORTHOPEDIC DRILL GUIDE Orthopedic Systems, Inc. | HSZ |
| Nov 19, 1986 | K864314 | EFTEKHAR RECHANNELIZATION DRILL GUIDE The Anspach Effort, Inc. | HSZ |
| Apr 25, 1986 | K861405 | REPLACEMENT HOSES Micro-Aire Surgical Instruments, Inc. | HSZ |
| May 3, 1985 | K851443 | MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER Micro-Aire Surgical Instruments, Inc. | HSZ |
| Mar 21, 1985 | K844130 | ACUFEX ARTHROSCOPIC SHAVER Acufex Microsurgical, Inc. | HSZ |
| Nov 29, 1984 | K844131 | NUCLEOTOME Medical Instrument Development Laboratories, Inc. | HSZ |
| Apr 4, 1984 | K840831 | ENDOTOME PNEUMATIC ORTHOPAEDIC CUT Cabot Medical Corp. | HSZ |
| Sep 29, 1983 | K831756 | ANSPACH 65,000 The Anspach Effort, Inc. | HSZ |
| Jul 20, 1981 | K811834 | MICRO OSCILLATING SAW Micro-Aire Surgical Instruments, Inc. | HSZ |
| Jun 15, 1981 | K811005 | CORB TM COUNTERROTATING BIOPSY NEEDLE Zimmer, Inc. | HSZ |
| Jan 9, 1981 | K803284 | OSTEO OSCILAIR Richard'S Medical Equip., Inc. | HSZ |
| Jun 9, 1980 | K801329 | ANSPACH INSTRUMENT CADDY The Anspach Effort, Inc. | HSZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.