Motor, Drill, Pneumatic
Regulation 882.4370
1510(k)s in 12 months (27 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in HBB
| Company | 510(k)s | Recalls |
|---|---|---|
| The Anspach Effort, Inc. | 3 | 6 |
| Aesculap, Inc. | 2 | 2 |
| Medtronic Powered Surgical Solutions | 2 | 2 |
| Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | 0 | 3 |
| Midas Rex Pneumatic Tools, Inc. | 3 | 0 |
| Sodemsystems | 3 | 0 |
| Power Surgical Solutions | 0 | 2 |
| Stryker Corp. | 2 | 0 |
| Adeor Medical AG | 1 | 0 |
| Aesculap Implant Systems LLC | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 2026 | K253772 | Velocity Alpha MR High Speed Surgical Drill System Adeor Medical AG, DE | HBB |
| Nov 9, 2018 | K172907 | ELAN 4 Air Motor System Aesculap, Inc. | HBB |
| Mar 23, 2017 | K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Att Medtronic Powered Surgical Solutions | HBB |
| May 22, 2015 | K150801 | Stryker Maestro Air Motors Stryker Corporation | HBB |
| Aug 24, 2010 | K101168 | LEGEND POWER ADAPTER MODEL: 6475000 Medtronic Sofamor Danek | HBB |
| Apr 14, 2010 | K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM Synthes (Usa) | HBB |
| Mar 26, 2009 | K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 Medtronic Powered Surgical Solutions | HBB |
| Jan 26, 2007 | K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM The Anspach Effort, Inc. | HBB |
| Oct 26, 2006 | K061725 | STRYKER ARIA PNEUMATIC SYSTEM Stryker Instruments | HBB |
| Jan 13, 2005 | K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM Medicon EG, DE | HBB |
| Sep 7, 2004 | K041754 | STRYKER MAESTRO SYSTEM Stryker Corp. | HBB |
| Apr 15, 2004 | K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM The Anspach Effort, Inc. | HBB |
| Nov 25, 2002 | K023066 | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) Sodemsystems, CH | HBB |
| Mar 18, 2002 | K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM Medtronic Midas Rex | HBB |
| Jan 25, 2002 | K013091 | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM Von Zeppelin GmbH, DE | HBB |
| Apr 20, 2000 | K000195 | CRANIAL DRILL Image-Guided Neurologics, Inc. | HBB |
| Dec 27, 1999 | K993851 | SODEM PERFORATOR DRIVE Sodemsystems, CH | HBB |
| Dec 21, 1999 | K994175 | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE Sodemsystems, CH | HBB |
| Jul 30, 1999 | K991625 | KOMET XK-95 PERFORATOR MOTOR (MI-102) Komet Medical | HBB |
| Nov 6, 1998 | K983092 | TRITON HUDSON CHUCK ATTACHMENT Mednext, Inc. | HBB |
| Sep 2, 1998 | K980686 | AESCULAP HILAN MOTOR SYSTEM Aesculap, Inc. | HBB |
| Sep 12, 1997 | K972289 | MIDAS REX MOTOR Midas Rex Pneumatic Tools, Inc. | HBB |
| Jan 22, 1997 | K954717 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY Sodem Diffusion SA | HBB |
| Nov 19, 1996 | K962483 | MIDAS REX III MOTOR Midas Rex Pneumatic Tools, Inc. | HBB |
| Nov 19, 1996 | K960630 | ANSPAHC SPEED REDUCER The Anspach Effort, Inc. | HBB |
| May 16, 1996 | K953434 | MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) Midas Rex Pneumatic Tools, Inc. | HBB |
| Oct 13, 1989 | K895739 | MICROMEDICS SURGICAL DRILL SYSTEM Micromedics, Inc. | HBB |
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