Panels › General, Plastic Surgery › Product code GET · Class 1
Motor, Surgical Instrument, Pneumatic Powered
Regulation 878.4820
0510(k)s in 12 months (23 all time)
0recalls in 12 months (54 all time)
3recalls that name a 510(k)
Top companies in GET
| Company | 510(k)s | Recalls |
|---|---|---|
| Linvatec Corp. | 0 | 47 |
| Midas Rex Pneumatic Tools, Inc. | 5 | 0 |
| Amsco Co. | 4 | 0 |
| Aesculap, Inc. | 1 | 1 |
| The Anspach Effort, Inc. | 0 | 2 |
| Power Surgical Solutions | 0 | 2 |
| Surgical Dynamics, Inc. | 2 | 0 |
| United States Surgical, A Division of Tyco Healthc | 2 | 0 |
| American Safety | 1 | 0 |
| American Silk Sutures, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 7, 1996 | K960473 | AESCULAP POWER SYSTEM HANDPIECE Aesculap, Inc. | GET |
| Jan 22, 1996 | K955174 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY Sodem Diffusion SA | GET |
| Oct 30, 1995 | K942987 | NUCLEOTOME L KIT Surgical Dynamics, Inc. | GET |
| Oct 18, 1995 | K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS Midas Rex Pneumatic Tools, Inc. | GET |
| Sep 15, 1995 | K953433 | MIDAS REX TELESCOPING SYSTEM Midas Rex Pneumatic Tools, Inc. | GET |
| Sep 14, 1995 | K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS Midas Rex Pneumatic Tools, Inc. | GET |
| Jul 17, 1995 | K952463 | GS & GS20 SURGICAL TOOL SYSTEM Midas Rex Pneumatic Tools, Inc. | GET |
| May 26, 1995 | K952300 | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) Midas Rex Pneumatic Tools, Inc. | GET |
| Jun 11, 1992 | K914753 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP United States Surgical, A Division of Tyco Healthc | GET |
| Mar 22, 1991 | K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART Sen Tech Medical Corp. | GET |
| Oct 30, 1990 | K904578 | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP United States Surgical, A Division of Tyco Healthc | GET |
| May 1, 1989 | K885066 | HEMATOME SYSTEM Surgical Dynamics, Inc. | GET |
| Sep 16, 1987 | K872951 | AMERICAN BRAIN RETRACTOR COVER American Silk Sutures, Inc. | GET |
| Sep 29, 1986 | K863447 | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II Stryker Corp. | GET |
| Dec 14, 1984 | K843498 | BIPOLAR SUCTION ELECTRODE Eder Instrument Co, Inc. | GET |
| Jul 23, 1984 | K840370 | SURG-A-STAT VASECTOMY TIP Suncoast Medical Manufacturers, Inc. | GET |
| Oct 31, 1983 | K833187 | HALL OSTEON Amsco Co. | GET |
| Aug 12, 1983 | K832188 | HALL RECIPROCATOR Amsco Co. | GET |
| Aug 12, 1983 | K832187 | HALL OSCILLATOR Amsco Co. | GET |
| Aug 12, 1983 | K832186 | HALL DRILL/REAMER Amsco Co. | GET |
| Jun 30, 1983 | K831675 | TWIST LOCK DRILL 1120 Micro-Aire Surgical Instruments, Inc. | GET |
| May 14, 1980 | K800382 | CLEAR-VIEW MIRROR WARMER Surgical Mechanical Research, Inc. | GET |
| Feb 26, 1979 | K790195 | FOOT VALVE American Safety | GET |
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