BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    PIONEER PRO-PUMP DUAL CONTROL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Damon 3

    FDA UDI
    ORMCO CORPORATION·00889989003505·U2L DAMON 3 .022 +10/+9/0 SUP/TQ

    COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STATIM CASSETTE AUTOCLAVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROPLEGE CORONARY SINUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DWF·January 14, 2013

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 3, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014

    ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    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