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

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    aprevo Transforaminal IBF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777440·LUMBAMED PLUS FLEX PAD WM SILVER II

    Anti-Leb (LE2)

    FDA UDI
    DIAGAST·23661562105421·Blood Grouping Reagent, Anti-Leb (Murine Monocl...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327376999·3-D PLATE, OBLIQUE

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180107397·5 MM DIA., 45 CM CUTTING ELECTRODE, RETRACTABLE...

    SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807210542601·Resolve® Ceramic M022 U4 -7T0A0O

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807210542101·Resolve® Ceramic R022 U4-5 -7T0A0O HU

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807210542611·Resolve® Ceramic M022 U4 -7T0A0O HU

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·November 27, 2019

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·August 10, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015