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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2025 | Aesculap AG AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. Open, Classified |
HBB | K172907 |
| Oct 2, 2025 | Aesculap AG AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. Open, Classified |
HBB | K172907 |
| Feb 15, 2018 | Aesculap Implant Systems LLC The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery. Terminated |
HBB | None listed |
| Jun 9, 2016 | Stryker Instruments Div. of Stryker Corporation Maestro Air Motor
Pneumatic cranial drill motor.
The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rota Terminated |
HBB | K150801 |
| May 4, 2016 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM.
Intended for use in neurosurgery. Terminated |
HBB | K020069 |
| Oct 21, 2015 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes. Terminated |
HBB | K020069 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBB | K040186 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBB | K040186 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBB | K960630 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HBB | K960630 |
| Jan 9, 2014 | The Anspach Effort, Inc. ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone. Terminated |
HBB | K061297 |
| Dec 17, 2009 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Medtronic Midas Rex Legend Footed Attachment, AF01.
Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications. Terminated |
HBB | K020069 |
| Aug 23, 2008 | Medtronic Powered Surgical Solutions Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23
Medtronic Powered Surgical Solutions, Forth Worth, TX
Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Terminated |
HBB | K020069 |
| Jul 11, 2007 | The Anspach Effort, Inc. Anspach Single Use, Sterile Bone Cutting Burrs Terminated |
HBB | K011444 K061297 +2 |
| Aug 3, 2005 | Medtronic Powered Surgical Solutions Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137. Terminated |
HBB | K020069 |
| Dec 4, 2004 | Power Surgical Solutions Medtronic Midas Rex Legend High Speed Pneumatic System Terminated |
HBB | K020069 |
| Nov 20, 2004 | Power Surgical Solutions Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas Terminated |
HBB | K020069 |
| Jan 9, 2003 | Medtronics Midas Rex Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge) Terminated |
HBB | K020069 |
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