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

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    A.L.P.S. Clavicle Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMILEY RETRACTOR

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 8, 2019

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486031916·SMILEY RETRACTOR

    SMILEY RETRACTOR

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 16, 2018

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706688·Desmarres Chalazion Forceps 3-1/2" (8.8cm), med...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515036215·U.S. Army Pattern Chisels 18mm, 6 1/2"

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450389980·

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK

    DEFIBRILLATOR ANALYZER - DA-2006P

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION

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

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 20, 2008

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 8, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 3, 2013

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 2, 2023

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·July 7, 2011

    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.

    FDA Enforcement
    Class II ·Terminated·Polymedco, Inc·April 10, 2013

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020