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

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    Insignia Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327466805·LE FORT I PLATE, 3MM ADVANCEMENT, LEFT

    BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSH·October 22, 2021

    INFRARED EAR THEROMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES

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

    TRULIANT TIB IMP PS INSERT SZ 3 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 11, 2024

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·November 16, 2016

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·October 20, 2008

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

    UNKNOWN DEPUY ASR CUP

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 8, 2013

    Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711-01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021