BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm

    FDA UDI
    SURETEK MEDICAL·B390KM332251·

    Brasseler USA

    FDA UDI
    Provision·00810041064943·

    Brasseler USA

    FDA UDI
    Provision·B504OMKM332250·

    NA

    FDA UDI
    STERILMED, INC.·10888551017114·SAW BLADE MICRO OSCILLATING 9 TEETH/CM STRYKER ...

    Critical Cover

    FDA UDI
    Alpha Pro Tech, Inc.·10817583023145·Scrub Pants, AlphaGuard, Dark Blue, Spandex Ela...

    E-FIT EF-1280 EMS MACHINE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 31, 2007

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 6, 2014

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 22, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·July 18, 2013

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023