BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003426·65 V2 SMALL 22ID STRGHT W/HG

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104875·PS3 Screw 5.5mm x 40mm

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024647534·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795002306·

    Plateau C

    FDA UDI
    Life Spine, Inc.·00190837093433·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493964·

    GENSTRIP TEST STRIP MODEL 100-201

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)

    FDA 510(k)
    FDA Class 2 ·Dental

    TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    SMARTSET HV 20G

    FDA Adverse Event
    Injury ·DEPUY CMW/REG. #9610921·Product code LOD·May 15, 2013

    PRIME ZOOM STRETCHER, 30"LITTER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·May 24, 2011

    WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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

    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