BEUDAMED
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    NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Twister™ Side-Fire Fiber Optic Delivery System

    FDA UDI
    Ceram Optec SIA·04049089100160·

    DD Bio Splint P

    FDA UDI
    Dental Direkt GmbH·EDDIK101151·DD Bio Splint P are transparent dental milling ...

    S-Core™

    FDA UDI
    SUBCHONDRAL SOLUTIONS, INC.·00850017962378·Size 8 Cannulated Sizer

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·10612479169200·CONTAINER, SHARPS TALL TRAY

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295000655·PROTRUSIO CAGE CEMENTED ACETABULAR RECONSTRUCTI...

    Zavation

    FDA UDI
    Zavation LLC·00197157009809·8.5mm TAP, CANNULATED

    PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP

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

    ENDURO MENISCAL COMPONENT F2 10MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

    IOLMASTER 500

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·November 14, 2024

    ELLIPSE DR, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 %, CELL

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·May 19, 2011

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 5, 2008

    Colonoscope, Model Number PCF-HQ190L.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025