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)
Top companies in HBG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | Medtronic Neurosurgery Ventriculostomy Kit, REF: 46154 Open, Classified |
HBG | K915546 |
| May 20, 2024 | Integra LifeSciences Corp. Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure.
Catalog Number: INS5HND Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra 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 |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra 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 |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra LifeSciences Corp. Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. Open, Classified |
HBG | K961113 |
| Feb 28, 2024 | Integra 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 |
HBG | K961113 |
| Dec 6, 2023 | Integra 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 |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: HITHSP04 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: HITHSP06 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7250 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7260 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7280 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7040 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra LifeSciences Corp. Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain.
Catalog Number: INS7270 Open, Classified |
HBG | K961113 |
| Dec 6, 2023 | Integra 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 |
HBG | K961113 |
| Aug 27, 2019 | Ad-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 |
HBG | K170442 |
| Sep 2, 2016 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND Terminated |
HBG | K961113 |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Dec 16, 2014 | Instrumed 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 |
HBG | None listed |
| Aug 26, 2013 | Integra 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 |
HBG | K902818 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
| Jan 13, 2012 | Integra 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 |
HBG | K961113 |
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