BEUDAMED
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    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 8, 2015

    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·October 23, 2013

    WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·November 15, 2017

    SurgAssist System Circular Stapler DLU 33mm

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GWD·November 20, 2003

    SurgAssist System Circular Stapler DLU 29mm

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GWD·November 20, 2003

    Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.

    FDA Recall
    Terminated ·Chiu Technical Corp·Product code HJM·November 9, 2007

    CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HJM·November 10, 2003

    Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

    FDA Recall
    Terminated ·Tosoh Bioscience, Inc.·Product code JCM·November 7, 2016

    Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JEC·August 17, 2005

    Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·March 15, 2010

    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 16, 2014

    Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 27, 2007

    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·June 13, 2014

    Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·November 10, 2006

    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·November 10, 2006

    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Chomedey (A-13) E Laval Canada·Product code HSB·May 29, 2019

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NDN·January 15, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NDN·January 15, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NDN·January 15, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NDN·January 15, 2013