BEUDAMED
    218 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

    FDA Enforcement
    Class II ·Terminated·Orthohelix Surgical Designs Inc·April 3, 2013

    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·November 20, 2019

    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.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    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

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·December 13, 2023

    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.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·February 28, 2018

    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·August 21, 2013

    Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·November 27, 2013

    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

    FDA Enforcement
    Class II ·Terminated·Biomet·June 17, 2020

    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·November 7, 2012