BEUDAMED
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    OCCLUSION BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MIXJECT

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108241068·MIXJECT 13mm w/27G Needle

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695359·Titanium Anatomic Straight Abutment Internal H...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306811319·Rochester Pean Hemostatic Forceps, Straight, 22 cm

    LYNX

    FDA UDI
    HNM TOTAL RECON LLC·00841742111391·LYNX ø4.0mm Cancellous Screw, Full Thread, Ti -...

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 25, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2025

    GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018

    CUSA EXCEL 23 KHZ CEM NOSECONE

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·April 15, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 21, 2011

    ACCU-CHEK ACTIVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    BABY CONTROL COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·October 24, 2022