BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040162245·Channels Flex Gutta Percha Points 40.04

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717108504·Needle Holder, Mayo-Hegar

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037307175·K-WIRE GUIDE Ø20 mm

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113416·PS Insert, Size 6 x 20mm

    JUGGERSTITCH CURVED IMPLANT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·November 7, 2019

    JUGGERSTITCH CURVED IMPLANT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·November 7, 2019

    JUGGERSTITCH CURVED IMPLANT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·November 7, 2019

    JUGGERSTITCH CURVED IMPLANT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·November 7, 2019

    INTRODUCER

    FDA UDI
    ELESTA SPA·08052286590135·CHIBA introducer needle, 21Gx11.7 cm

    PBN FALLOPIAN TUBE CATHETER SYSTEM

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

    SURESMILE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    NA

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code DSP·March 21, 2013

    DEFINIUM 8000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code KPR·February 10, 2011

    COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD, FORMERLY DELTEC INC.·Product code LZG·March 28, 2008

    ITREL 4

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 2, 2016

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017

    Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-108155 21-108157 21-108159 21-108251 21-108253 21-108255 21-108257 21-108259 21-108271 21-108273 21-108275 21-108277 21-108279 21-108291 21-108293 21-108295 21-108297 21-108299 21-108391 21-108393 21-108395 21-108397 21-108399 21-109256 21-109260 21-109264 21-109268 21-109272 21-123202 21-123203 21-123204 21-123205 21-123206 21-123207 21-123208 21-123209 21-123210 21-123211 21-123212 21-124309 21-124310 21-124311 21-124312 21-124313 21-124314 21-124315 21-124316 21-124317 US157338 US157340 US157342 US157344 US157346 US157348 US157350 US157352 US157354 US157356 US157358 US157359 US157360 X21-180307 X21-180308 X21-180309 X21-180310 X21-180311 X21-180312 X21-180313 X21-180314 X21-180315 X21-180316 X21-180317 X21-180318 X21-180319 X21-180320 X21-180321 X21-182308 X21-182309 X21-182310 X21-182311 X21-182312 X21-182313 X21-182314 X21-182315 X21-182316 X21-182317 X21-182318 X21-182319 X21-182320 X21-182321 Product Usage: Hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019