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

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    MECHANICAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694002516·H Plate

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707008941·CALIBRA 1ST MOLAR BANDS n.UR 32

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450048658·

    GlucoLeader Enhance Blood Glucose Test Strip(for PTA)

    FDA UDI
    HMD BIOMEDICAL INC.·04711200721898·GlucoLeader Enhance GL Blood Glucose Test Strip...

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962106228·ø3.2mm STEINMANN PIN, 12", SINGLE TROCAR (ROUND...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694063500·1.2 System H Plate Sterile Qty 2

    APEX MEDICAL MINI TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GMK HINGE FIXED TIBIAL INSERT SIZE 5 14MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 1, 2014

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    ADAPTA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·May 20, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

    RENAISSANCE 29 P-WASHOBS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·May 26, 2011

    V.A.C. FREEDOM THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

    Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size 1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component Catalog: 05-01-0033.

    FDA Recall
    Terminated ·Endotec, Inc.·Product code JWH·June 5, 2009

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 30, 2025