BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    PICO SHINING (PICO-K; PICOFY)

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

    BD BBL™ Bio-Bag™ Environmental Chamber Type A

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902612149·Bag Bio-Bag Type A 100 Ea

    SKYHAWK

    FDA UDI
    Orthofix US LLC·18257200094974·14MM ROTATING CUTTER

    Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AQUARIUSAPS SERVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 12, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 12, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 21, 2022

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 28, 2024

    STENT

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code OUT·March 16, 2026

    ATLAS PLUS HF CRT-D

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 11, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 23, 2011

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·August 2, 2013

    Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·June 15, 2022

    Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52737 MWCE-18-7-3-NESTER G52736 MWCE-18-3-2-NESTER-01 G47331 MWCE-18-5-2-NESTER-01 G47333 MWCE-18-2-2-NESTER-01 G47344 MWCE-18-5-5-NESTER-01 G47335 MWCE-18-7-2-NESTER G52735 MWCE-18-7-4-NESTER-01 G47339 MWCE-18-7-10-NESTER G52741 MWCE-18-5-5-NESTER G23520

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·June 15, 2022

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020