BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    EVER-SHARP BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    Snowden-Pencer

    FDA UDI
    STERIS CORPORATION·10885403278624·Snowden-Pencer MIS SWITCH-BLADE MINI METZENBAUM...

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825018009·Curved Mini Metzenbaum Scissor Tip

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867055131·PLATE, POW, LOCKING, TI, 3 MM

    UNKNOWN V. MUELLER DEVICE

    FDA Adverse Event
    Injury ·CAREFUSION·Product code GEI·March 23, 2015

    OPTI-TEARS(R)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NON-STERILE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 20MM F/IM NAILS-STER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·January 23, 2014

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 25, 2014

    VENT TUBE 1016010 5PK GOODE T 1.14X12MM

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code ETD·January 3, 2013

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTORNIC NEUROMODULATION·Product code EZW·November 8, 2010

    SWITCH-BLADE CLICKFIT REUSE HNDL 5MM36CM

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code GEI·October 5, 2011

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017