BEUDAMED
    21 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.

    NOVALIS (SHAPED BEAM SURGERY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    RMO

    FDA UDI
    Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST

    RMO

    FDA UDI
    Rmo, Inc.·00885797099730·LING RETNR BOND 3X3 6 CASE KIT

    Natus

    FDA UDI
    XLTEK·00382830020855·P32-STIM POD 2 (E-H)-10' (CR)

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103476·BRACKET NARROW TWIN MAX RIGHT/MAND LEFT CUSPID ...

    LIFEPAK® 12 defibrillator/monitor

    FDA UDI
    PHYSIO-CONTROL, INC.·00885074269290·LP12AABCAAAABBABAAAAAAAALP12 MONITOR-DEFIB

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148820·Straight Implant Trial 25mm x 9mm x 9mm

    STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK, VANCOMYCIN 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 10, 2024

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 18, 2025

    PORTEX GENERAL ANESTHESIA CIRCUITS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022

    TRIATHLON #7 CR INSERT 11MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 13, 2013

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·January 28, 2011

    PUMP MMT-522RNAL PRDGM INS CL EN RC

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·February 26, 2008

    Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG. REINFORCED XLGE TOWEL I WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014

    Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG. REINFORCED XLGE TOWEL I WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025