Drills, Burrs, Trephines & Accessories (Compound, Powered)
Regulation 882.4305
1510(k)s in 12 months (19 all time)
2recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in HBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Codman & Shurtleff, Inc. | 6 | 0 |
| Integra LifeSciences Corp. (NeuroSciences) | 0 | 4 |
| Acra Cut, Inc. | 3 | 0 |
| The Anspach Effort, Inc. | 2 | 0 |
| Adeor Medical Technologies GmbH | 1 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 1 | 0 |
| Evonos GmbH & Co. KG | 1 | 0 |
| Guizhou Zirui Technology Co., Ltd. | 1 | 0 |
| Integra Lifesciences Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K254177 | Disposable Sterile Skull Drill (LZ) Guizhou Zirui Technology Co., Ltd., CN | HBF |
| Mar 6, 2024 | K231403 | evoDrill Cranial Perforator Evonos GmbH & Co. KG, DE | HBF |
| Jun 20, 2022 | K213228 | NeuroLine Disposable Cranial Perforator with Hudson end Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft., HU | HBF |
| Jan 20, 2019 | K183581 | Codman Disposable Perforators Integra Lifesciences Corp. | HBF |
| Mar 16, 2015 | K141455 | EASYDRILL AUTOSTOP CRANIAL PERFORATOR Micromar Ind. Com. , Ltd. | HBF |
| Jul 17, 2012 | K121253 | MERIDIAN CRANIAL PERFORATOR Adeor Medical Technologies GmbH, DE | HBF |
| Dec 29, 2008 | K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT Stryker Ireland Ltd., Instruments Division, IE | HBF |
| Dec 22, 2008 | K082637 | CRANIAL PERFORATOR The Anspach Effort, Inc. | HBF |
| Jan 4, 2008 | K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 Codman & Shurtleff, Inc. | HBF |
| Oct 22, 2007 | K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 Codman & Shurtleff, Inc. | HBF |
| Dec 8, 2003 | K032970 | ACRA-CUT XPRESS 120 Acra Cut, Inc. | HBF |
| Oct 21, 1998 | K982991 | ANSPACH ACCESS CRANIAL PERFORATOR The Anspach Effort, Inc. | HBF |
| Dec 10, 1993 | K933894 | DISPOSABLE PERFORATOR Codman & Shurtleff, Inc. | HBF |
| Jul 8, 1993 | K924242 | DISPOSABLE PERFORATOR Codman & Shurtleff, Inc. | HBF |
| Jun 15, 1989 | K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) Acra Cut, Inc. | HBF |
| Jan 22, 1988 | K875019 | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR Neurodynamics, Inc. | HBF |
| Dec 29, 1983 | K833266 | ACRA-CUT Acra Cut, Inc. | HBF |
| Feb 4, 1982 | K820087 | CODMAN * REUSABLE PERFORATOR Codman & Shurtleff, Inc. | HBF |
| Aug 28, 1979 | K791101 | DISPOSABLE PERFORATORS, JACOBS, HUDSON Codman & Shurtleff, Inc. | HBF |
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