BEUDAMED
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    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Enforcement
    Class II ·Terminated·Hand Biomechanics Lab Inc·October 26, 2016

    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Recall
    Terminated ·Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany·Product code HBL·July 5, 2018

    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Recall
    Terminated ·Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany·Product code HBL·July 5, 2018

    IMRIS MR/X-ray head fixation device, Model HFD200

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code HBL·June 26, 2019

    Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBL·November 11, 2020

    Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code HBL·February 17, 2022

    MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·June 29, 2004

    Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBL·August 29, 2013

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code HBL·February 11, 2015

    IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

    FDA Recall
    Terminated ·Deerfield Imaging·Product code HBL·August 14, 2017

    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

    FDA Recall
    Terminated ·Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany·Product code HBL·July 5, 2018

    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.

    FDA Recall
    Terminated ·Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany·Product code HBL·November 2, 2017

    ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGL·March 26, 2009

    ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·June 9, 2005

    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

    ABL 800 FLEX series blood gas analyzers containing software version 5.24.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·November 13, 2006

    ABL 700 Series blood gas analyzers equipped with Software Version 3.833.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·November 13, 2006