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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ORION WATCHGUARD

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746108921·DB BKT MINI MS UL LAT 022 T+3 A+9 R=0

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981142124·Mariner Implant Tray, 5.5 Rod and Crossbar Caddy

    Rampart One Lumbar Interbody Fusion Device

    FDA UDI
    SPINEOLOGY INC.·M7404902104·Rampart One Oblique Spacer

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707051617·.022 U6L STD/NC -10T 5 OFF

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 15, 2024

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 15, 2024

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 15, 2024

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 15, 2024

    COMBINED PHYSIOLOGICAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 30, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·November 10, 2010

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code HET·January 8, 2013

    30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; Spinning Spiros Closed Male Luer, Red Cap, REF: CH2000S-C; Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10; Spiros, Closed Male Luer w/Red Cap, 5 Units, REF: CH2000SC-5; Spinning Spiros Closed Male Luer, Purple Cap, REF: CH2000S-PC; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC; Spiros, Purple Cap, Drop-In Priming Cap, REF: CH2000S-PCP; Spinning Spiros Closed Male Luer w/Red Cap, REF: CH3515; Spinning Spiros Closed Male Luer, REF: Z7072

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023