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Panels › Neurology › Product code HBE · Class 2

Drills, Burrs, Trephines & Accessories (Simple, Powered)

Regulation 882.4310

2510(k)s in 12 months (65 all time)
19recalls in 12 months (258 all time)
203recalls that name a 510(k)
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Top companies in HBE

Company510(k)sRecalls
The Anspach Effort, Inc.7104
Stryker Instruments Div. of Stryker Corporation094
Surgify Medical OY419
Stryker714
Stryker Instruments Division of Stryker Corporation013
Aesculap, Inc.50
EXP Pharmaceutical Services Corp04
Medtronic Xomed, Inc.22
Aesculap Implant Systems LLC03
Biomet Microfixation21
Decided510(k)Device and applicantCode
Mar 26, 2026K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1);
Surgify Medical OY, FI
HBE
Nov 6, 2025K250815Hubly Drill (H100)
Hubly, Inc.
HBE
Oct 31, 2025K252060GREEN
Phasor Health, LLC
HBE
Sep 19, 2025K252662UniBur
Nakanishi, Inc., JP
HBE
Jun 4, 2025K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1);
Surgify Medical OY, FI
HBE
Mar 13, 2025K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1)
Surgify Medical OY, FI
HBE
Mar 11, 2025K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur
Stryker Instruments
HBE
Nov 29, 2023K232684Surgify Halo
Surgify Medical OY, FI
HBE
May 4, 2023K230619Hubly Electric Drill (H100)
Hubly, Inc.
HBE
Nov 15, 2022K2231992.1 x 255mm Drill, 22mm Stop
Biomet Microfixation
HBE
Aug 23, 2022K2130722.1 x 255mm Drill, 22mm Stop
Biomet Micofixation
HBE
Dec 23, 2021K213208Twist Drills
Biomet Microfixation
HBE
Nov 23, 2021K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex
Medtronic Powered Surgical Solutions
HBE
Oct 22, 2021K202120P300 Attachment
Nakanishi, Inc., JP
HBE
Aug 24, 2021K203739ELAN 4 Electro Motor System
Aesculap, Inc.
HBE
Jun 30, 2021K210377Stryker iBur hubs and cutting accessories
Stryker Corporation
HBE
Apr 11, 2021K191479Velocity Alpha Highspeed Surgical Drill System
Adeor Medical AG, DE
HBE
Aug 9, 2019K183203ELAN 4 Tools
Aesculap, Inc.
HBE
Jul 19, 2019K183545Anspach Helix Dissection Tools
The Anspach Effort, Inc.
HBE
Jun 18, 2019K191049Stryker MIS and Footed Attachments
Stryker Corporation
HBE
Jun 14, 2019K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Stryker
HBE
Jan 19, 2019K182527ELAN 4 Tools
Aesculap, Inc.
HBE
Oct 17, 2018K172709ELAN 4 Electro Motor System Tools
Aesculap, Inc.
HBE
Oct 4, 2018K182436POWEREASE System
Medtronic Sofamor Danek USA, Inc.
HBE
Sep 7, 2017K170442Cranial Drill Bits and Accessories
Ad-Tech Medical Instrument Corporation
HBE
May 19, 2017K162542OsteoMed PINNACLE Driver
Osteomed
HBE
Dec 1, 2016K161704Phasor Drill
Biotex, Inc.
HBE
Mar 16, 2016K153519DReal
Carevature Medical, Ltd., IL
HBE
May 8, 2015K143399Stryker Footed Attachments and Cutting Accessories
Stryker Corp.
HBE
May 1, 2015K143540Stryker MIS Attachments and Cutting Accessories
Stryker Corporation
HBE
Apr 23, 2015K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Stryker Corp.
HBE
Jun 27, 2014K130755HICUT HIGHSPEED INSTRUMENT
Adeor Medical AG, DE
HBE
Mar 20, 2014K132436VARIOGUIDE DRILL KIT
Mri Interventions, Inc.
HBE
Jan 11, 2013K123270POWEREASE SYSTEM
Medtronic Sofamor Danek USA, Inc.
HBE
Aug 27, 2012K121264TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
Medtronic Surgical Technologies
HBE
Dec 16, 2011K113476ANSPACH DISSECTION TOOLS
The Anspach Effort, Inc.
HBE
Oct 26, 2011K111520IPC POWEREASE SYSTEM
Medtronic Xomed, Inc.
HBE
Oct 17, 2008K081475ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
Medtronic Xomed, Inc.
HBE
Apr 30, 2008K080802EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
The Anspach Effort, Inc.
HBE
Sep 18, 2007K072315MIDAS REX CURVED BUR
Medtronic Powered Surgical Solutions
HBE
Apr 27, 2007K070876STRYKER TWIST DRILLS
Stryker Craniomaxillofacial
HBE
Dec 4, 2006K062842TWIST DRILL
Walter Lorenz Surgical, Inc.
HBE
Apr 7, 2005K050628ANSPACH COUPLER
The Anspach Effort, Inc.
HBE
Dec 17, 2004K042783ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
The Anspach Effort, Inc.
HBE
Mar 15, 2004K040076ANSPACH ADVANCED MICRO SAW ATTACHMENTS
The Anspach Effort, Inc.
HBE
Jan 16, 2004K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Stryker Instruments
HBE
Apr 3, 2003K030172SMALL HIGH SPEED MOTOR DRILL SYSTEM
Brasseler USA I, L.P.
HBE
Oct 21, 2002K022942CRANIOCUT
Aesculap, Inc.
HBE
Mar 5, 2002K014060MICROAIRE 1000E SYSTEM
Microaire Surgical Instruments, Inc.
HBE
Oct 24, 2000K002903ANSPACH ANGLED MICRONOSE ATTACHMENT
The Anspach Effort, Inc.
HBE

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