BEUDAMED
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    Invisalign System

    FDA 510(k)
    FDA Class 2 ·Dental

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160151·Integra® Miltex® DeBakey Aortic Aneurysm Clamp,...

    Turbo

    FDA UDI
    SPINAL ELEMENTS·00840916118242·Turbo MIS TLIF, Titanium, 24mm long x 14 mm wid...

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996166072·TIGER SHARK,STERILE,STR,9X24X14,12 DEG

    ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STERILUCENT SELF-SEAL STERILIZATION POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HWE·May 20, 2025

    TRIATHLON ASYM PATELLA A40X11

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·November 10, 2014

    SERIES 20000 LEGACY

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 18, 2011

    RECONSTRUCTIVE WEDGE P1 18X15X7

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HRS·July 22, 2013

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018