BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    ONLINE VALPROIC ACID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RMO

    FDA UDI
    Rmo, Inc.·00885797100085·QUAD HELIX ASST 5

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"

    SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAHN TAPERED IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 20, 2024

    COMPR 12MM IM HMRL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019

    ZB 12/14 COCR HD 32MM X +0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 29, 2024

    SCD 700 COMPRESSION SYSTEM - US

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code JOW·March 26, 2013

    SILIMED

    FDA Adverse Event
    Injury ·*·Product code FWM·June 10, 2008

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 8, 2011

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.

    FDA Recall
    Terminated ·Theken Spine Llc·Product code KWQ·July 29, 2010

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016