BEUDAMED
    21 results · 19ms · Sources: EU EUDAMED, US FDA

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    IM-6 MICROINJECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Premier Cavity Prep

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008371·CALIF CUTTING INSTR 38/39

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780156956·Integra® Jarit® Valve Spring, 1-5/8", For Ref #...

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00533041·

    3M™ Unitek™ APC™ Clarity™ MBT™

    FDA UDI
    3M UNITEK CORPORATION·00652221236890·APC FF Clarity Ultra SL MBT U Rt Lateral 10T/8A...

    HARDYDISK, TETRACYCLINE 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OSCAR 2, MODEL 222

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYBRID OFFSET SHELL INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LXH·April 4, 2019

    EFFICIA DFM100

    FDA Adverse Event
    Injury ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.·Product code MKJ·November 23, 2023

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·December 17, 2010

    HYBRID OFFSET SHELL INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code LXH·April 10, 2016

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    INFUSOMAT SPACE ACM-KIT

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·July 31, 2014

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 27, 2008

    HYBRID OFFSET SHELL INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·May 18, 2016

    Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2

    FDA Recall
    Terminated ·VIASYS Med Systems·Product code CAI·September 10, 2003

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·November 4, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018