BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ATEC 0909-20

    FDA UDI
    Hologic, Inc.·15420045504844·9G (3.7MM) X 9CM, 20MM HANDPIECE

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P09092070·9mm PLIF Implant 9mm Wide 20mm Length, 7 deg Lo...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450223826·

    TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ATEC 0912-20 HANDPIECES

    FDA Adverse Event
    Other ·SUROS SURGICAL SYSTEMS, INC.·Product code GDF·February 1, 2007

    ATEC 0912-20 HANDPIECES

    FDA Adverse Event
    Other ·SUROS SURGICAL SYSTEMS, INC.·Product code GDF·February 1, 2007

    ATEC 0912-20 HANDPIECES

    FDA Adverse Event
    Other ·SUROS SURGICAL SYSTEMS, INC.·Product code GDF·February 1, 2007

    ATEC 0909-20

    FDA Adverse Event
    Injury ·HOLOGIC, INC·Product code KNW·February 14, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    BELT CLIP MMT-642

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·May 2, 2011

    ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278. The handpiece is inserted into the breast to the site of the area of interest. When the proper location/[position is achieved, the handpiece cuts and removes biopsy tissue.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KNW·February 1, 2010

    VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT LEFT 65MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 25, 2019

    VANGUARD CRUCIATE RETAINING E1 ANTIOXIDANT INFUSED TIBIAL BEARING 12MM X 71/75MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 25, 2019

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020