BEUDAMED
    822 results · 22ms · Sources: EU EUDAMED, US FDA

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    TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Per-Q-Cath Plus Midline Catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741037627·Per-Q-Cath Plus Midline Catheter 2F Single-Lume...

    MEGA PLUS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665580122·Rod(CoCr), Ø6.0 x 120mm

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00190376215648·Fixed 2.3mm Drill Bit, 12mm

    RAVINE Lateral Access System

    FDA UDI
    VB Spine LLC·10888857560581·Lateral Access Blade Size 24x180 mm

    HOMOCYSTEINE MICROTITER PLATE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIGITAL RADIOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·December 10, 2007

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 29, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    ACCU-CHEK RAPID D INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·August 19, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 21, 2012

    LIGAMAX 5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·June 11, 2007

    PINNACLE MTL INS NEUT36IDX62OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 17, 2012

    PERMANENT PACEMAKER ELECTRODE

    FDA Adverse Event
    Malfunction ·PACESETTER·Product code DTB·August 12, 2023

    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·July 4, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM INC.·Product code MDS·March 28, 2014

    MAHURKAR 13.5FRX13.5CM PC KIT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·June 29, 2012

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code NVN·August 11, 2023

    PERMANENT PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code DTB·August 12, 2023