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    ULTRASOUND SCANNER TYPE 2102

    FDA 510(k)
    FDA Class 2 ·Radiology

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741108167·Catheter Placement Kit

    Preat

    FDA UDI
    Preat Corporation·00842092165607·NobelBiocare™ Tri-Lobe-compatible RP Titanium B...

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0005671·CC/ Effect Enamel SI-03 heavy yellow

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·09010782021576·CC/ Effect Enamel SI-03 heavy yellow

    DIALY-NATE

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H67140005670·SET WITH LUER CONNECTORS AND A 4-WAY STOPCOCK, ...

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092165614·NobelBiocare™ Tri-Lobe-compatible RP – Milled ...

    SECURMIX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 12, 2013

    BLADELESS VP 11MM ST W/ FIXATION

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code GCJ·February 1, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 15, 2008

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·April 10, 2020

    SENSATION 7FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DSP·February 12, 2018

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DSP·February 22, 2018

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·January 4, 2022

    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