BEUDAMED
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    ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741129650·Catheter Placemen Kit

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862161390·

    CRANIALMAP

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327327205·CRANIALMAP SERVICE UPGRADE

    CRANIALMAP

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327327175·CRANIALMAP ENABLE

    CRANIALMAP

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327327137·CRANIALMAP UPGRADE

    CRANIALMAP

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327327199·CRANIALMAP

    BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007

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

    RX G-UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    DATASCOPE INTRA-AORTIC PUMP

    FDA Adverse Event
    Death ·DATASCOPE CORP.·Product code DSP·May 6, 2014

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    GOODBABY·Product code INM·March 12, 2013

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 16, 2011

    PRECISION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·February 21, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 25, 2016

    BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006

    FDA Recall
    Open, Classified ·Product code FMF·May 12, 2025

    BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·June 18, 2025

    BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

    FDA Recall
    Open, Classified ·Bard Access Systems, Inc.·Product code LJS·March 11, 2025

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

    FDA Enforcement
    Class I ·Ongoing·Bard Access Systems, Inc.·April 23, 2025