BEUDAMED
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    GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Enamelite

    FDA UDI
    Keystone Industries·H66851001971·AEROpaque Spray Opaque Shade D3 Medium

    InnoSpire Elegance

    FDA UDI
    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730001647·Innospire Elegance, 120V 60HZ (US) without Hand...

    DOYEN SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896092679·DOYEN SCISSORS STRAIGHT SERRATED BLADE POWER CU...

    COOLEY DUCTUS CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921001970·COOLEY PATENT DUCTUS CLAMP STRAIGHT JAW ANGLED ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450173282·

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

    CORTEK CYSTOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

    VACUETTE TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code GIM·April 20, 2021

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 18, 2014

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·May 16, 2011

    BD PHASEAL PROTECTOR P50J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023

    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    FDA Enforcement
    Class II ·Terminated·Kreg Medical Inc.·June 12, 2013

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025