BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    PPA/BT-RB STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HHM

    FDA UDI
    Oticon A/S·05707131257062·H160, BTE 13 WL 85 DBL HHM

    Vu cPOD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981039523·Implant Tapered 12x14x5mm (Non-Strut)

    INFUSION SET FOR POWERPICC SOLO 2 CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GIVEN DIAGNOSTIC SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·March 19, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    LIGASURE V 5 MM SEALER DIVIDER

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 13, 2011

    Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.

    FDA Recall
    Terminated ·Megadyne Medical Products, Inc.·Product code GEI·February 27, 2014

    Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 3, 22.5 mm; Ref 96-2346.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    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