Drills, Burrs, Trephines & Accessories (Manual)
Regulation 882.4300
1510(k)s in 12 months (17 all time)
1recalls in 12 months (54 all time)
40recalls that name a 510(k)
Top companies in HBG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2025 | K252696 | LEGACY Phasor Health, LLC | HBG |
| Jan 18, 2017 | K153587 | Taps for Resorbable Screws Synthes (USA) Products, LLC | HBG |
| Jan 12, 2017 | K162884 | SpineGuard DSG Zavation Screw System Spineguard S.A., FR | HBG |
| Mar 26, 2016 | K160129 | MRII Cranial Drill and Accessories Mri Interventions, Inc. | HBG |
| Jul 8, 2015 | K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm Mri Interventions, Inc. | HBG |
| Mar 22, 2013 | K122456 | MRII CRAINIAL DRILL Mri Interventions, Inc. | HBG |
| Nov 12, 2002 | K022712 | HAND DRILL, MODEL 11-9901-7 Medical Design, LLC | HBG |
| Oct 18, 2002 | K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES Medtronic Xomed, Inc. | HBG |
| Jun 5, 1996 | K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL Clinical Neuro Systems, LLC | HBG |
| Aug 5, 1993 | K932402 | MODIFICATION TO GHAJAR GUIDE TWIST DRILL Neurodynamics, Inc. | HBG |
| Dec 30, 1991 | K915546 | PS MEDICAL VENTRICULOSTOMY KIT Pudenz-Schulte Medical Research Corp. | HBG |
| Oct 3, 1990 | K904283 | PS MEDICAL CRANIAL HAND DRILL Pudenz-Schulte Medical Research Corp. | HBG |
| Sep 20, 1990 | K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT Ruggles Corp. | HBG |
| May 5, 1989 | K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON Zinnanti Surgical Instruments, Inc. | HBG |
| Jan 28, 1988 | K875018 | GHAJAR GUIDE TWIST DRILL Neurodynamics, Inc. | HBG |
| Dec 30, 1987 | K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES Solway, Inc. | HBG |
| Jul 18, 1986 | K862160 | CAMINO HAND DRILL - MODEL 030 Camino Laboratories, Inc. | HBG |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.