BEUDAMED
    17 results · 30ms · 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 ×

    STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

    FDA 510(k)
    FDA Class 2 ·Hematology

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Enforcement
    Class III ·Terminated·Diagnostica Stago, Inc.·September 24, 2014

    Flexitron

    FDA UDI
    Nucletron B.V.·08717213026674·Flexitron Transfer Tube for Metal Needles (16)

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376513744·TL VBR 16 mm CORE HT TRIAL, 18/22 mm

    PIT AND FISSURE CHEMICAL CURING SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503514194·TPU,Side bend,11.5Fr,18cm working length with 2...

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503515801·TPU,Straight,11.5Fr,18cm working length with 22...

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503514439·TPU,Center bend,11.5Fr,18cm working length with...

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·July 21, 2005

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·May 7, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 26, 2011

    CONCERTO

    FDA Adverse Event
    Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code FPO·August 14, 2008

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024

    LIBRE 2 SENSOR FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021