BEUDAMED
    15 results · 29ms · 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 ×

    Anatomic Bone Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695502P221088S1·PLIF 22mm x 8mm x 10mm x 8 °, TyPEEK, Sterile

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695302P221088S1·PLIF 22mm x 8mm x 10mm x 8 °, PEEK, Sterile

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021

    IQ FLEX M

    FDA Adverse Event
    Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

    Grosz Play Feel

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

    JOGUIDE CARDIOVASCULAR GUIDING C ATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 13, 2020

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL,INC.·Product code NAY·August 23, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·November 3, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·July 3, 2013

    injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

    FDA Enforcement
    Class II ·Ongoing·Labories Medical Technologies·May 10, 2023

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Recall
    Completed ·SynCardia Systems LLC·Product code LOZ·August 1, 2023

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022