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

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    i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000035099·PROSTHESIS 1133002 CUP PISTON .6X4.5 SST

    Robinson

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490034388·PROSTHESIS 1133002 CUP PISTON .6X4.5 SST

    Contours™ Finishing & Polishing Discs 3/8" Starter Kit

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883006167·Aluminum oxide dental finishing and polishing a...

    CONMED

    FDA UDI
    Conmed Corporation·20653405041105·COAXIAL BIPOLAR ADAPTER 2, ELECTROSURGICAL ADAPTER

    Contours™ Finishing & Polishing Discs 3/8" Starter Kit

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016674·Aluminum oxide dental finishing and polishing a...

    Primary Lens Set, 28D, 90D, 3 Mirror

    FDA UDI
    KATENA PRODUCTS, INC.·00841668144268·

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·August 9, 2016

    VITAL SYNC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024

    EXPERT TN Ø8 SOLID L285 TAN DBLUE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDS·May 29, 2013

    EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Malfunction ·VOLCARIA S.R.L.·Product code OBJ·September 29, 2014

    ACCESS® 2I (LXI) IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 17, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2014

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·May 26, 2021

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·July 25, 2016

    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·November 25, 2020

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024