BEUDAMED
    22 results · 27ms · 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 ×

    VARILIFT -C

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037308516·TRIAL HUMERAL CUP 135/145° MOBILITY Ø32 +3

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383505628·Gutta Percha Points is used to root canal filin...

    CT/MR Contour Prostate Template Insert, 1.65mm lrg

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330023391·

    CT/MR Contour Prostate Template Insert, 2mm lrg

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330023421·

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018104·Wide Jaw Punch medium 15 degree up milled 3.5mm...

    CT/MR Contour Prostate Template Insert, 18G, lrg

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330023414·

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857551220·Offset Blade Right Size 60 mm

    CT/MR Contour Prostate Template Insert, 17G, lrg

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330023407·

    RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

    FDA 510(k)
    FDA Class 2 ·Immunology

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/16MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 20, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·June 10, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·August 12, 2008

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code CIB·July 28, 2003

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015