BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    CLARISCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Inverted Reamer Z-S Hall ø 48

    FDA UDI
    Spierings Orthopaedics B.V.·08720256027324·

    DEROYAL SURGICAL, UMBILICUP

    FDA 510(k)
    FDA Class 2 ·Hematology

    FLIGHT 60 VENTILATOR, MODEL F-60

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TARGET DEVICE 300X160MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·April 9, 2012

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 10, 2011

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 20, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 15, 2008

    BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·August 5, 2022

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018