BEUDAMED
    37 results · 23ms · Sources: EU EUDAMED, US FDA

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    PSK ENDOSCOPE CLEANING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040093778·Maxima Reamers 25mm

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950016617·CURETTE IMPLANT ROUND CUPS 5X10MM & 6X20MM 5-1/...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810002161·REAMERS

    NA

    FDA UDI
    DEPUY SPINE, LLC·10705034007113·SPINAL INSTRUMENT TRIAL SPACER 15 x 17 x 25mm

    6051-0000-216

    FDA UDI
    CITY TECHNOLOGY LIMITED·B404605100002160·

    QB1 NMES System

    FDA UDI
    Motive Health, Inc.·00854691008254·QB1 NMES System; S/M, Left

    Synergy Disc Instruments

    FDA UDI
    Synergy Spine Solutions Inc·M670910000021609·Ø3.5mm X16mm Distraction Pin

    e-vive NMES System; Small/Medium, Left (2.0 Dock)

    FDA UDI
    Motive Health, Inc.·00854691008414·e-vive NMES System; Small/Medium, Left (2.0 Dock)

    BARCOMED 5MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMR CEMENTLESS MINI STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·January 20, 2021

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·January 27, 2023

    IAB : 8 FR - 40 CC

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·June 22, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·March 12, 2013

    PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·February 18, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·February 19, 2008

    FEMORAL MODULAR HEAD - XL Ø40MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LPH·August 9, 2023

    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000216, Manufactured at: Warsaw, Indiana, USA

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017