BEUDAMED
    15 results · 36ms · 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 ×

    DISPOSABLE CIRCULAR STAPLER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Oticon

    FDA UDI
    Oticon A/S·05707131255419·SENSEI PRO, RITE 312 WL CBE DEMO

    COE-FLEX®

    FDA UDI
    Gc America Inc.·10386040004930·COE-FLEX® s Injection Type (catalyst only) (1 x...

    COE-FLEX®

    FDA UDI
    Gc America Inc.·D6581313031·COE-FLEX® s Injection Type (catalyst only) (1 x...

    AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DERMATOLOGICAL TREATMENT DEVICE FAMILY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD LUER-LOK¿ TIP 3ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·November 16, 2021

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 17, 2013

    VITA 2 DDDR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·June 16, 2011

    RUMI SYSTEM

    FDA Adverse Event
    Malfunction ·COOPER SURGICAL·Product code LKF·August 5, 2008

    BD PHOENIX¿ PMIC/ID-107

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 18, 2024

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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