BEUDAMED
    28 results · 23ms · Sources: EU EUDAMED, US FDA

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    CKMB UDR ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Farrow Toe Cap

    FDA UDI
    BSN MEDICAL, INC.·04042809612776·FARROW 15-20 MM HG TOE CAP MEDIUM BLACK 1

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814695·GENUMEDI SILVER SIZE VI

    ILIZAROV SYSTEMS

    FDA UDI
    MEDICALPLASTIC SRL·28033201841994·WASHER 2.0MM FIXATION BOLT

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180510278·Bayonetted Osteotome, 1/4"

    Navigated Spine Instruments

    FDA UDI
    VB Spine LLC·10888857549418·Navigated Awl Tap Size Ø7.5 mm

    IM2001 PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI

    FDA 510(k)
    FDA Class 2 ·Hematology

    CARDIOHELP SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015

    LS LF MACR EXT ST (CAS/48)

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·May 2, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 15, 2023

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 15, 2023

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 14, 2023

    VERCISE CARTESIA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·August 3, 2024

    Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·May 20, 2026

    6F Z2 GUIDING CATH SR4.0 SH CATHETER Z26SR40SH Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR40SH

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025