BEUDAMED
    15 results · 26ms · 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.

    HAND MASSAGE UNIT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    X-CORE

    FDA UDI
    Nuvasive, Inc.·00887517266378·XC Mini Endcap, 16mm Parallel Round Ø14

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526814721·GENUMEDI PSS GREEN O

    Cortera

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311209347·Guidewire, SS, Sharp Tip, 400

    Gait Trainer 3

    FDA UDI
    SPORT MEDICAL TECHNOLOGY INC.·00718175005408·Gait Trainer 3, 115 VAC, 50/60 Hz

    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Renu Gel

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CADD PCA AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Death ·PHARMACIA DELTEC, INC.·Product code MEA·October 6, 1995

    ASR 300 SPIKED CUP SIZE 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 6, 2011

    COMPRESS SEGMENTAL ANCHOR PLUG 14MM W/DRILL SET AND W/PIN INSERTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·November 16, 2016

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 24, 2024

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DXC·February 22, 2024

    Comprehensive Reverse Shoulder System Humeral Tray Model 115340

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·February 22, 2017