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

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    JETSTREAM G3 (R) SF 1.6 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390876254·

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390876261·

    LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEVILBISS 9000 SERIES CPAP, MODEL 9001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390885775·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390885768·

    RESTYLYANE INJECTABLE GEL

    FDA Adverse Event
    Other ·Q-MED AB·Product code LMH·February 28, 2013

    UNKNOWN DEPUY HIP LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 14, 2013

    REST ASSURED, GEN II

    FDA Adverse Event
    Malfunction ·RANIR, LLC·Product code OBR·September 23, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 2, 2011

    EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2024

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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