BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    PECTOFIX STERNAL REPAIR WIRE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964024786·The ENDO CARRY-ON Procedure Kit contains all of...

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328761·TEMPLATE 3003951 ZEVO 51MM 3 LVL

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048302531·POST INSULATED ANTERIOR

    LUXAFORM

    FDA 510(k)
    FDA Class 2 ·Dental

    PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SECURE FLOW

    FDA Adverse Event
    Injury ·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012

    GEL-FILLED MAMMARY IMPLANT LP, 240 CC

    FDA Adverse Event
    DOW CORNING CORP.·Product code FTR·November 2, 1994

    HIGH PROFILE MAMMARY IMPLANT, 440 CC

    FDA Adverse Event
    MCGHAN MEDICAL CORP.·Product code FTR·November 2, 1994

    ROUND PROSTHESIS, 340 CC

    FDA Adverse Event
    UNKNOWN·Product code FTR·November 2, 1994

    LOW PROFILE BREAST IMPLANT, 340 CC

    FDA Adverse Event
    UNKNOWN·Product code FTR·November 2, 1994

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 23, 2025

    BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    SPRINTER LEGEND RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code LOX·March 14, 2013

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 1, 2011

    TA

    FDA Adverse Event
    Malfunction ·COVIDIEN UNITED STATES SURGICAL CORPORATION·Product code GAG·February 1, 2008

    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 18, 2018

    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KQO·November 10, 2017

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013