BEUDAMED
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    Prism

    FDA 510(k)
    FDA Class 2 ·Neurology

    BIOPHEN PLASMA CALIBRATOR

    FDA UDI
    HYPHEN BIOMED·03663537008252·

    Bernafon

    FDA UDI
    Bernafon AG·05714464009640·AO7 MNR T R SABE/MSIL ALIGO 7 GPL

    SLIDE-ON® ENDOSHEATH®

    FDA UDI
    MEDTRONIC XOMED, INC.·20763000037837·SHEATH 222101 20PK MACHIDA ENT-2L

    Steril Peel

    FDA UDI
    AMD Medicom Inc·D830222101·STERIL-PEEL Self Seal Sterilization Pouch Size ...

    SLIDE-ON®

    FDA UDI
    MEDTRONIC XOMED, INC.·20613994394587·SHEATH 222101 20PK MACHIDA ENT-2L

    SLIDE-ON® ENDOSHEATH®

    FDA UDI
    MEDTRONIC XOMED, INC.·20763000089607·SHEATH 222101 20PK MACHIDA ENT-2L

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707040064·DB BRACKETS MINI 22 CEN U

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 15, 2002

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707098096·EXACONNECT PLUS 2.2 STRAIGHT GH1,5

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517074789·

    MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C

    FDA 510(k)
    FDA Class 2 ·Hematology

    CLEAN FLASH

    FDA Adverse Event
    Injury ·MED-TECH LTD·Product code KDJ·November 5, 2008

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON INC·Product code HET·August 24, 2011

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 2, 2013

    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

    FDA Enforcement
    Class III ·Terminated·Michigan Instruments, Inc.·May 16, 2018

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023