BEUDAMED
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    OSTEOGRAF/LD-300 HYDROXYLAPATITE

    FDA 510(k)
    FDA Class 2 ·Dental

    SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741100536·SureStep™ Foley Tray System Bard® Lubri-Sil® F...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094185782·Single Use Ear Tips for OAE Hearing Screener an...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094185775·Single Use Ear Tips for OAE Hearing Screener an...

    BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD INC. (COVINGTON) -1018233·Product code EZL·October 10, 2025

    SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® CATHETER

    FDA Adverse Event
    Malfunction ·C. R. BARD, INC.·Product code EZL·September 12, 2022

    IMPLANTMASTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Pyrenees Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BENDING/CUTTING PLIERS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTC·June 12, 2020

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 3, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP·Product code LZG·December 21, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 17, 2014

    SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter

    FDA Recall
    Terminated ·Bard Medical Division·Product code MJC·December 13, 2018

    Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter

    FDA Enforcement
    Class II ·Terminated·Bard Medical Division·February 13, 2019