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 |
|---|---|---|---|
| Feb 19, 1980 | K800275 | CEBOTOME DRILL American Sterilizer Co. | HSZ |
| Jul 30, 1979 | K791056 | 3M CEMENT REMOVER 3M Company | HSZ |
| Apr 23, 1979 | K790645 | ENDOTOME Berkeley Bio-Engineering | HSZ |
| Dec 20, 1978 | K781979 | SURGAIRTOME TWO American Sterilizer Co. | HSZ |
| Feb 1, 1978 | K780139 | PNEUMATIC POWERED BUR North Palm Beach Orthodepic Assoc. | HSZ |
| Jan 3, 1978 | K772324 | WIREDRIVER American Sterilizer Co. | HSZ |
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