BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517297761·CoRoent® XLK, 14x18x55mm

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517286741·CoRoent® XL-CTW, 14x22x55mm

    Vu aPod™ - L

    FDA UDI
    Seaspine Orthopedics Corporation·10889981046309·LATERAL IMPLANT, WIDE, STANDARD, 14mm X 23mm X ...

    BACT/ALERT FN PLUS CULTURE BOTTLE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    GYNECARE MESH UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTM·May 2, 2018

    RETENTION BONE-SCREW DRIVER

    FDA Adverse Event
    Injury ·PRECISION SPINE, INC.·Product code HXX·April 21, 2015

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    RELION ULTIMA METER

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE·Product code LFR·August 9, 2011

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTO·July 8, 2013

    COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNSOTICS, LTD.·Product code JJF·October 4, 2010

    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

    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