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

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    Solitaire Platinum Revascularization Device, 6x40 mm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)

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

    PLATELIA ASPERGILLUS EIA, MODEL 62793

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 11, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    PREVENA INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KCI USA, INC.·Product code OMP·July 7, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013

    CENTRICITY RA1000

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE INTEGRATED IT SOLUTIONS·Product code LLZ·September 1, 2008

    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    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