Product Code: HBE


Products Classified as HBE

3705Drills, Burrs, Trephines & Accessories (simple, Powered)Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories.

Total Product Life Cycle (TPLC) Devices

3705Drills, Burrs, Trephines & Accessories (simple, Powered)Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories.

Pre-market Notifications for HBE

K213454Midas 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 7.5mmMedtronic Powered Surgical Solutions
K213208Twist DrillsBiomet Microfixation
K210377Stryker IBur Hubs And Cutting AccessoriesStryker Corporation
K202120P300 AttachmentNakanishi Inc.
K191479Velocity Alpha Highspeed Surgical Drill SystemAdeor Medical AG
K191049Stryker MIS And Footed AttachmentsStryker Corporation
K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker
K183545Anspach Helix Dissection ToolsThe Anspach Effort, Inc.
K183203ELAN 4 ToolsAesculap, Inc.
K182527ELAN 4 ToolsAesculap, Inc.
K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.
K172709ELAN 4 Electro Motor System ToolsAesculap, Inc.
K170442Cranial Drill Bits And AccessoriesAd-Tech Medical Instrument Corporation
K162542OsteoMed PINNACLE DriverOSTEOMED
K161704Phasor DrillBIOTEX, INC.

Global Unique Device Identification Database

00613994952066DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994952028DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994952011DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994951991DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994933713DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994933706DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994917713DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994917706DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994917638DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994917607DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994905710DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994905697DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994905673DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994905666DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
00613994905611DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Maude Adverse Events

SAGITTAL SAW ATTACHMENTSTRYKER INSTRUMENTS-KALAMAZOO2020-03-31
MATRIX 1.1MM DRILL BIT/HXC 4MM STOP/52MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
2.3MM TAPERED ROUTERSTRYKER INSTRUMENTS-KALAMAZOO2020-03-31
1.5MM WIRE PASS DRILL BITSTRYKER INSTRUMENTS-KALAMAZOO2020-03-31
PERFORATOR DRIVER,60:1 RATIODEPUY SYNTHES PRODUCTS LLC2020-03-27
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-03-27
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-03-26
3.0MM CARBIDE MATCH HEADSTRYKER INSTRUMENTS-KALAMAZOO2020-03-24
3.0MM CARBIDE MATCH HEADSTRYKER INSTRUMENTS-KALAMAZOO2020-03-23
3.0MM CARBIDE MATCH HEADSTRYKER INSTRUMENTS-KALAMAZOO2020-03-23
IPC? HANDPIECE ATTACHMENT - INDIGO? DRILLMDT POWERED SURGICAL SOLUTIONS2020-03-23
3MM FLUTED MATCHSTICK, 15CMDEPUY SYNTHES PRODUCTS LLC2020-03-20
1.55MM X 10MM TWIST DR,SDEPUY SYNTHES PRODUCTS LLC2020-03-19
MINIMAL ACCESS ATTACHMENTDEPUY SYNTHES PRODUCTS LLC2020-03-18
TRAUMAONE SYSTEM DRILL, 1.6X115MM 26MM STOPBIOMET MICROFIXATION2020-03-17
UNKNOWN_INSTRUMENTS_PRODUCTSTRYKER INSTRUMENTS-KALAMAZOO2020-03-17
UNKNOWN_INSTRUMENTSTIRE_PRODUCTSTRYKER INSTRUMENTS-KALAMAZOO2020-03-17
PERFORATOR DRIVER,60:1 RATIODEPUY SYNTHES PRODUCTS LLC2020-03-17
1.55MM X 10MM TWIST DR,SDEPUY SYNTHES PRODUCTS LLC2020-03-17
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-03-17
MINIMAL ACCESS ATTACHMENTDEPUY SYNTHES PRODUCTS LLC2020-03-17
1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOPBIOMET MICROFIXATION2020-03-16
UNKNOWN_INSTRUMENTSTIRE_PRODUCTSTRYKER INSTRUMENTS-KALAMAZOO2020-03-16
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-03-13
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-03-12
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-03-11
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-03-11
UNKNOWN_INSTRUMENTSTIRE_PRODUCTSTRYKER INSTRUMENTS-KALAMAZOO2020-03-11
MOTOR LEGEND EHS STYLUS REFURBMDT POWERED SURGICAL SOLUTIONS2020-03-10
1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOPBIOMET MICROFIXATION2020-03-10
IPC? HANDPIECE - STYLUS TOUCH?MEDTRONIC XOMED INC.2020-03-09
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-03-09
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-03-06
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-03-06
MINIMAL ACCESS ATTACHMENTDEPUY SYNTHES PRODUCTS LLC2020-03-06
XPS? CLEARVIEW - LEGEND TOOLMEDTRONIC XOMED INC.2020-03-05
1.55MM X 10MM TWIST DR,SDEPUY SYNTHES PRODUCTS LLC2020-03-04
1.55MM X 10MM TWIST DR,SDEPUY SYNTHES PRODUCTS LLC2020-03-04
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-03-04
MINIMAL ACCESS ATTACHMENTDEPUY SYNTHES PRODUCTS LLC2020-03-03
XPS? CLEARVIEW - LEGEND TOOLMEDTRONIC XOMED INC.2020-03-03
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-03-03
IPC? HANDPIECE ATTACHMENT - INDIGO? DRILLMDT POWERED SURGICAL SOLUTIONS2020-03-03
LEGEND TAPERED DISSECTING TOOLMDT POWERED SURGICAL SOLUTIONS2020-03-02
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-03-02
1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 15MM STOPBIOMET MICROFIXATION2020-02-28
1.1MM STRAIGHT ROUTERSTRYKER INSTRUMENTS-KALAMAZOO2020-02-28
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-02-28
COMPACT SPEED REDUCER, 60:1DEPUY SYNTHES PRODUCTS LLC2020-02-28
IPC? HANDPIECE - INDIGO? DRILLMEDTRONIC XOMED INC.2020-02-28
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.