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

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    HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAART 200 AORTIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·CORCYM INC.·Product code KRH·May 8, 2025

    HAART 200 AORTIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·CORCYM INC.·Product code KRH·May 9, 2025

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180164352·SNOOK HOOK

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776170042·SNOOK HOOK

    GLOBUS GENESY 1100 STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 17, 2024

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KNW·March 12, 2026

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013

    QUICKIE 2 LITE

    FDA Adverse Event
    Malfunction ·SUNRISE MEDICAL (US) LLC·Product code IOR·June 29, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 17, 2008

    CNS-6801A

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·November 13, 2019

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code LWE·October 8, 2025

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

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

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021