Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation 882.4310
1510(k)s in 12 months (65 all time)
19recalls in 12 months (258 all time)
203recalls that name a 510(k)
Top companies in HBE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 1999 | K984035 | XK-95 HIGH SPEED MOTOR DRILL SYSTEM Komet Medical | HBE |
| May 18, 1995 | K943541 | 75K STAIGHT DRILL Stryker Corp. | HBE |
| May 3, 1994 | K935861 | MEDNEXT BUR Mednext, Inc. | HBE |
| Mar 16, 1993 | K930229 | CLINICAL NEURO SYSTEMS CRANIAL DRILL Clinical Neuro Systems, LLC | HBE |
| Oct 13, 1992 | K922299 | ZEPPELIN MOTOR DRILL SYSTEM Von Zeppelin Chirurgische Instrumente GmbH, DE | HBE |
| Sep 10, 1991 | K911819 | ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED Acra Cut, Inc. | HBE |
| Sep 10, 1991 | K911812 | ACRA-CUT WIRE PASS DRILL Acra Cut, Inc. | HBE |
| Dec 21, 1990 | K905097 | MICRO-AIRE MODEL NUMBER: MK-426 Micro Surgical Instruments Corp. | HBE |
| Nov 13, 1990 | K902703 | CRANIOTOME BLADE OR DRILL BIT A. Henniss | HBE |
| Sep 13, 1990 | K903664 | MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL Micro-Aire Surgical Instruments, Inc. | HBE |
| May 7, 1990 | K900388 | MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES Midas Rex Pneumatic Tools, Inc. | HBE |
| May 31, 1988 | K881418 | CRANIOTOME BLADE OR NEURO BLADE Nuell Air Equipment & Hospital Supplies, Inc. | HBE |
| May 6, 1988 | K880601 | WIRE PASS DRILL BITS Nuell Air Equipment & Hospital Supplies, Inc. | HBE |
| Jan 28, 1988 | K875224 | HUDSON CRANINAL BURRS Tri-Med, Inc. | HBE |
| Dec 17, 1987 | K873692 | RAYLOR(TM) DRILL STOP Cedar Surgical, Inc. | HBE |
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