BEUDAMED
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    RUSCH FLONEIL; FLOCATH INTROGEL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743670·ACHIMED ACHILLES SUPP SILVER IV

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540602603·Bone Screws, MP, Cross-Pin

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221231451·Unitek Miniature Twin MBT LL 2Bi -17T/2A DHk 02...

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837010027·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837009922·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837050788·10mmx20mmx14mm Plateau-P, 7 Degree Reverse Angle

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH, INC.·Product code QJR·April 6, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·April 5, 2021

    VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WARTNER WART REMOVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROATION KNEE

    FDA Adverse Event
    Injury ·MATORHTO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Malfunction ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    MEDIAL ROTATION KNEE

    FDA Adverse Event
    Injury ·MATORTHO LIMITED·Product code JWH·January 22, 2016

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code CBI·March 18, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 7, 2011

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008