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Panels › Neurology › Product code HBG · Class 2

Drills, Burrs, Trephines & Accessories (Manual)

Regulation 882.4300

1510(k)s in 12 months (17 all time)
1recalls in 12 months (54 all time)
40recalls that name a 510(k)
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Top companies in HBG

DateFirm and productCodeLinked 510(k)
Jul 21, 2026Medtronic Neurosurgery
Ventriculostomy Kit, REF: 46154
Open, Classified
HBGK915546
May 20, 2024Integra LifeSciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Feb 28, 2024Integra LifeSciences Corp.
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Open, Classified
HBGK961113
Dec 6, 2023Integra LifeSciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
Open, Classified
HBGK961113
Aug 27, 2019Ad-Tech Medical Instrument Corporation
AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Terminated
HBGK170442
Sep 2, 2016Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Terminated
HBGK961113
Dec 16, 2014Instrumed International, Inc.
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix Internation
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion br
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instrument
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix Internatio
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFus
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, Care
Terminated
HBGNone listed
Dec 16, 2014Instrumed International, Inc.
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
Terminated
HBGNone listed
Aug 26, 2013Integra Limited
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining re
Terminated
HBGK902818
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 S
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP Monitoring Kit, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra Life
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 Wes
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra Lif
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage:
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile and non-sterile, Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage:
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile
Terminated
HBGK961113
Jan 13, 2012Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile,
Terminated
HBGK961113

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