BEUDAMED
    12 results · 20ms · 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.

    NEORAY DR 2520 DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Non-Locking Screw, 2.7mm x 48mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026467·

    MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ALL TERRAIN WHEELCHAIR (ATW)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAS·April 29, 2013

    SECURA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·May 10, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·July 23, 2008

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;

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

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015