HBE

Injury

306

Malfunction

7,175

Other

1

Total

7,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K253627 — Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) Surgify Medical OY · 2026-03-26
• K250815 — Hubly Drill (H100) Hubly, Inc. · 2025-11-06
• K252060 — GREEN Phasor Health, LLC · 2025-10-31
• K252662 — UniBur Nakanishi, Inc. · 2025-09-19
• K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) Surgify Medical OY · 2025-06-04
• K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) Surgify Medical OY · 2025-03-13
• K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R Stryker Instruments · 2025-03-11
• K232684 — Surgify Halo Surgify Medical OY · 2023-11-29
• K230619 — Hubly Electric Drill (H100) Hubly, Inc. · 2023-05-04
• K223199 — 2.1 x 255mm Drill, 22mm Stop Biomet Microfixation · 2022-11-15
• K213072 — 2.1 x 255mm Drill, 22mm Stop Biomet Micofixation · 2022-08-23
• K213208 — Twist Drills Biomet Microfixation · 2021-12-23
• K213454 — Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm Medtronic Powered Surgical Solutions · 2021-11-23
• K202120 — P300 Attachment Nakanishi, Inc. · 2021-10-22
• K203739 — ELAN 4 Electro Motor System Aesculap, Inc. · 2021-08-24
• K210377 — Stryker iBur hubs and cutting accessories Stryker Corporation · 2021-06-30
• K191479 — Velocity Alpha Highspeed Surgical Drill System Adeor Medical AG · 2021-04-11
• K183203 — ELAN 4 Tools Aesculap, Inc. · 2019-08-09
• K183545 — Anspach Helix Dissection Tools The Anspach Effort, Inc. · 2019-07-19
• K191049 — Stryker MIS and Footed Attachments Stryker Corporation · 2019-06-18
• K190172 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker · 2019-06-14
• K182527 — ELAN 4 Tools Aesculap, Inc. · 2019-01-19
• K172709 — ELAN 4 Electro Motor System Tools Aesculap, Inc. · 2018-10-17
• K182436 — POWEREASE System Medtronic Sofamor Danek USA, Inc. · 2018-10-04
• K170442 — Cranial Drill Bits and Accessories Ad-Tech Medical Instrument Corporation · 2017-09-07
• K162542 — OsteoMed PINNACLE Driver Osteomed · 2017-05-19
• K161704 — Phasor Drill Biotex, Inc. · 2016-12-01
• K153519 — DReal Carevature Medical, Ltd. · 2016-03-16
• K143399 — Stryker Footed Attachments and Cutting Accessories Stryker Corp. · 2015-05-08
• K143540 — Stryker MIS Attachments and Cutting Accessories Stryker Corporation · 2015-05-01
• K143320 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker Corp. · 2015-04-23
• K130755 — HICUT HIGHSPEED INSTRUMENT Adeor Medical AG · 2014-06-27
• K132436 — VARIOGUIDE DRILL KIT Mri Interventions, Inc. · 2014-03-20
• K123270 — POWEREASE SYSTEM Medtronic Sofamor Danek USA, Inc. · 2013-01-11
• K121264 — TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE Medtronic Surgical Technologies · 2012-08-27
• K113476 — ANSPACH DISSECTION TOOLS The Anspach Effort, Inc. · 2011-12-16
• K111520 — IPC POWEREASE SYSTEM Medtronic Xomed, Inc. · 2011-10-26
• K081475 — ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] Medtronic Xomed, Inc. · 2008-10-17
• K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL The Anspach Effort, Inc. · 2008-04-30
• K072315 — MIDAS REX CURVED BUR Medtronic Powered Surgical Solutions · 2007-09-18
• K070876 — STRYKER TWIST DRILLS Stryker Craniomaxillofacial · 2007-04-27
• K062842 — TWIST DRILL Walter Lorenz Surgical, Inc. · 2006-12-04
• K050628 — ANSPACH COUPLER The Anspach Effort, Inc. · 2005-04-07
• K042783 — ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM The Anspach Effort, Inc. · 2004-12-17
• K040076 — ANSPACH ADVANCED MICRO SAW ATTACHMENTS The Anspach Effort, Inc. · 2004-03-15
• K032303 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Instruments · 2004-01-16
• K030172 — SMALL HIGH SPEED MOTOR DRILL SYSTEM Brasseler USA I, L.P. · 2003-04-03
• K022942 — CRANIOCUT Aesculap, Inc. · 2002-10-21
• K014060 — MICROAIRE 1000E SYSTEM Microaire Surgical Instruments, Inc. · 2002-03-05
• K002903 — ANSPACH ANGLED MICRONOSE ATTACHMENT The Anspach Effort, Inc. · 2000-10-24
• K984035 — XK-95 HIGH SPEED MOTOR DRILL SYSTEM Komet Medical · 1999-06-03
• K943541 — 75K STAIGHT DRILL Stryker Corp. · 1995-05-18
• K935861 — MEDNEXT BUR Mednext, Inc. · 1994-05-03
• K930229 — CLINICAL NEURO SYSTEMS CRANIAL DRILL Clinical Neuro Systems, LLC · 1993-03-16
• K922299 — ZEPPELIN MOTOR DRILL SYSTEM Von Zeppelin Chirurgische Instrumente GmbH · 1992-10-13
• K911812 — ACRA-CUT WIRE PASS DRILL Acra Cut, Inc. · 1991-09-10
• K911819 — ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED Acra Cut, Inc. · 1991-09-10
• K905097 — MICRO-AIRE MODEL NUMBER: MK-426 Micro Surgical Instruments Corp. · 1990-12-21
• K902703 — CRANIOTOME BLADE OR DRILL BIT A. Henniss · 1990-11-13
• K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL Micro-Aire Surgical Instruments, Inc. · 1990-09-13
• K900388 — MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES Midas Rex Pneumatic Tools, Inc. · 1990-05-07
• K881418 — CRANIOTOME BLADE OR NEURO BLADE Nuell Air Equipment & Hospital Supplies, Inc. · 1988-05-31
• K880601 — WIRE PASS DRILL BITS Nuell Air Equipment & Hospital Supplies, Inc. · 1988-05-06
• K875224 — HUDSON CRANINAL BURRS Tri-Med, Inc. · 1988-01-28
• K873692 — RAYLOR(TM) DRILL STOP Cedar Surgical, Inc. · 1987-12-17