BEUDAMED
    18 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

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

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517444363·SpheRx® II Conn, 50mm Transverse Fixed

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776089610·Debakey Acutely Curved Clamp,

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702404128·Elvarex 2/Thigh High/Closed Toe, E-Version, Kne...

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180158955·Elmed Multi-Flex Neuro Retractor and Handrest S...

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277125019·Auerbach Arm Holder Rake Retractor Set

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160168·Integra® Miltex® DeBakey Aortic-Aneurysm Clamp,...

    OPTIO-C ANTERIOR CERVICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STARPACS ORTHOPEDICS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vacutron

    FDA UDI
    Allied Medical, LLC·00026072019603·Suction Regulator

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code QFG·April 15, 2022

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 10, 2014

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·September 9, 2011

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 22, 2013

    AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·October 21, 2020

    AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FIP·September 1, 2020

    various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017