ClearanceBrief
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)
Get daily alerts for HBESample briefCSV

Top companies in HBE

DateFirm and productCodeLinked 510(k)
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK250380
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK250380
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK250380
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK250380
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK250380
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK251433
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK251433
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK251433
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Jun 24, 2026SURGIFY MEDICAL OY
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Open, Classified
HBEK253627
Aug 27, 2025Medtronic Xomed, Inc.
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surge
Open, Classified
HBEK111520
Jul 29, 2025Phasor Health, LLC
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Open, Classified
HBEK161704
Jan 17, 2025Stryker Corporation
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Open, Classified
HBEK143320
Jan 17, 2025Stryker Corporation
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Open, Classified
HBEK143320
Jan 17, 2025Stryker Corporation
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat
Open, Classified
HBEK143320
Oct 11, 2024Stryker Corporation
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not
Open, Classified
HBEK143320
Aug 26, 2024Stryker Corporation
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medic
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following med
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical app
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical ap
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical app
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical a
Completed
HBEK210377
Aug 26, 2024Stryker Corporation
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical a
Completed
HBEK210377
Jun 24, 2022Stryker Instruments
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Open, Classified
HBEK143320
Oct 21, 2021Medtronic Xomed, Inc.
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ
Open, Classified
HBEK081475
May 2, 2018Ad-Tech Medical Instrument Corporation
AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The d
Terminated
HBEK170442
Sep 5, 2017Aesculap Implant Systems LLC
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN
Terminated
HBENone listed
Sep 5, 2017Aesculap Implant Systems LLC
ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING
Terminated
HBENone listed
Sep 5, 2017Aesculap Implant Systems LLC
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 EL
Terminated
HBENone listed
Dec 21, 2016Stryker Instruments Div. of Stryker Corporation
8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting acce
Terminated
HBENone listed
Dec 21, 2016Stryker Instruments Div. of Stryker Corporation
8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting acce
Terminated
HBENone listed
Dec 21, 2016Stryker Instruments Div. of Stryker Corporation
8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory con
Terminated
HBENone listed
Dec 21, 2016Stryker Instruments Div. of Stryker Corporation
8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting acce
Terminated
HBENone listed
Dec 21, 2016Stryker Instruments Div. of Stryker Corporation
8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting acce
Terminated
HBENone listed
Dec 21, 2016Stryker Instruments Div. of Stryker Corporation
8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting
Terminated
HBENone listed
Dec 21, 2016Stryker Instruments Div. of Stryker Corporation
8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting
Terminated
HBENone listed
Oct 6, 2016The Anspach Effort, Inc.
IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system
Terminated
HBEK040186
Oct 6, 2016The Anspach Effort, Inc.
IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
Terminated
HBEK040186

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.