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

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    BERMAN INTUBATING/PHARYNGEAL AIRWAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613025700·Bruns Scissor, Curved Up, Large Serrated Blades...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450672501·

    SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARBODISSECTING ENDOSCOPE

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

    MULTI SPECT 2 [510(K) K913630]

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001

    ABLATOR - S

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE·Product code GEI·December 3, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·January 14, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 3, 2014

    FEMORAL STEM CMK OC MODULAR CEMENTED

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code JDI·October 30, 2017

    STAINLESS STEEL MODULAR HEAD

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code JDI·October 30, 2017

    RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LZO·October 17, 2017

    COBALT HV BONE CEMENT 40GRAMS-JAPAN

    FDA Adverse Event
    Death ·BIOMET ORTHOPEDICS·Product code LOD·September 23, 2016

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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