BEUDAMED
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    STERITEC EMU-GRAPH, MODEL NO. CI 131/US

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIDAS® Progesterone

    FDA UDI
    BIOMERIEUX SA·03573026156954·VIDAS ® Progesterone (PRG) assay is a quantitat...

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001205·

    Summit Medical

    FDA UDI
    Summit Medical, Inc.·00385640068918·

    KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION

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

    FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0409010·CR Tibial Insert, UHMWPE + Vitamin E, Size 4, ...

    NA

    FDA UDI
    USA INSTRUMENTS, INC.·00840682145589·

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code BZD·February 14, 2022

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·April 8, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MPROC, VILLALBA·Product code EZW·March 23, 2011

    LASIK

    FDA Adverse Event
    Injury ·Product code LZS·May 9, 2008

    VIDAS PRG Progesterone, REF 30409-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code JLS·September 22, 2021

    VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JLS·November 9, 2022

    VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    VIDAS PRG Progesterone, REF 30409-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS® PROGESTERONE

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JLS·January 12, 2023

    VIDAS® PROGESTERONE

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JLS·January 12, 2023

    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

    VIDAS® PROGESTERONE 60 TESTS

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLS·December 9, 2021