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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator 9mm. Cranial Perforator. Open, Classified |
HBF | K183581 |
| Nov 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator 11mm. Cranial Perforator. Open, Classified |
HBF | K183581 |
| May 6, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit. Open, Classified |
HBF | K073336 |
| May 6, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator, 14mm. Cranial perforator. Open, Classified |
HBF | K183581 |
| Nov 6, 2020 | Stryker Instruments Div. of Stryker Corporation Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients.
Catal Terminated |
HBF | K082010 |
| Jan 11, 2012 | Biomet Microfixation, Inc. Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 15 Terminated |
HBF | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.