BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    VeriSplint

    FDA 510(k)
    FDA Unclassified ·Unknown

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199281·AK3 PS Notch Reamer Guide Size 6+

    CONMED

    FDA UDI
    Conmed Corporation·10845854021415·OSCILLATING SAW BLADE 19 X 1.07 X 90 MM

    MClass

    FDA UDI
    Conmed Corporation·10845854021002·MCLASS OSCILLATING SAW BLADE 19 X 1.07 (0.042")...

    SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    MINI TIGHTROPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 18, 2019

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·October 21, 2014

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·August 4, 2011

    NOVOPEN 3 DEMI

    FDA Adverse Event
    Other ·NOVO NORDISK A/S·Product code FMF·June 21, 2013

    DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·May 27, 2020

    BD¿ BLUNT FILL NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code GAA·May 1, 2019

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·December 25, 2019

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·July 31, 2019

    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up 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