BEUDAMED
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    VANGUARD ASYMMETRICAL PATELLAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRESTLE LUXE

    FDA UDI
    ALPHATEC SPINE, INC.·00190376215068·TRESTLE LUXE II, ACP, 3-LEVEL, 62

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306816130·Mayo-Adams Retractor, 3 Blades, 17cm

    Utrecht Interstitial Fletcher CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213034877·Interstitial Ovoid (left) 35mm 15°, R10

    CAMBRIDGE HEART OEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK COMFORT CURVE TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 26, 2024

    TELAMON FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 1, 2011

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024