BEUDAMED
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    ARTHROCARE ENT COBLATOR SURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PIRANHA

    FDA UDI
    Richard Wolf GmbH·04055207054734·FOOTSWITCH 1 PEDAL for Piranha Suction Pump 2208

    Asnis

    FDA UDI
    Stryker GmbH·07613154577989·CANNULATED SCREW

    Humelock Reversed Shoulder

    FDA UDI
    FX SOLUTIONS·03701037306192·HUMELOCK REVERSED REAMER Ø8mm

    Discectomy Set

    FDA UDI
    SPINEOLOGY INC.·M7403030108·14mm Shaver

    SEFI MEDICAL INSTRUMENTS

    FDA registration
    SEFI MEDICAL INSTRUMENTS·1 product·🇮🇱 Israel

    USS-LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    REAMER SHAFT, MOD, TRINKLE 8.0X284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012

    POWER CONTROL

    FDA Adverse Event
    Malfunction ·RICHARD WOLF GMBH·Product code HRX·November 3, 2020

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    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code LWS·January 14, 2013

    INFUSOR SV 2, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 27, 2011

    CONSERVE PLUS SPIKED CUP

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·April 14, 2008

    TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·February 14, 2018

    Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.

    FDA Enforcement
    Class III ·Terminated·Mindray DS USA, Inc. dba Mindray North America·April 4, 2018

    TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·July 14, 2017

    PIRANHA

    FDA Adverse Event
    Malfunction ·RICHARD WOLF GMBH·Product code JCX·December 8, 2021

    PIRANHA

    FDA Adverse Event
    Injury ·RICHARD WOLF GMBH·Product code JCX·October 30, 2024

    PIRANHA

    FDA Adverse Event
    Malfunction ·RICHARD WOLF GMBH·Product code JCX·February 24, 2025

    PIRANHA SUCTION PUMP

    FDA Adverse Event
    Malfunction ·RICHARD WOLF GMBH·Product code JCX·November 15, 2019