BEUDAMED
    34 results · 31ms · Sources: EU EUDAMED, US FDA

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    SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169599123·TRIAL 2190560 O25 IB 27MM 0 DEG 16X60

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029042410·4 Bicuspid Extraction w/Seating Springs

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306804724·Cartilage Crushing Box

    EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIOLOX DELTA CER LNR 36MM E

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code LZO·February 5, 2026

    RINGLOC-X E1 H/W 56/36MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·April 27, 2026

    BIOLOX DELTA CER LNR 40MM G

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·April 27, 2026

    PROSTIVA

    FDA Adverse Event
    Malfunction ·MPROC, VILLALBA·Product code KNS·October 6, 2008

    UNKNOWN M2A MAGNUM HIP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    CAPIO SUTURE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GAW·November 2, 2007

    REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·December 11, 2025

    AVAN E1 INSERT 28 S 52

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·March 6, 2025

    BIOLOX DELTA CER LNR 32MM E

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·September 8, 2025

    RINGLOC BIPOLAR VIVACIT-E

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·September 10, 2025

    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·November 11, 2024

    REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022

    REVOLUTION PHISIO CENTRIFUGAL PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021