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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    V-Laser

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

    UNBRANDED

    FDA UDI
    ADVANCE MEDICAL DESIGNS, INC.·00848340008900·Uroview Consumable

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139233081·Unity ASC Size 4 Tibial Template Trial

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482001400·Symmetry® Curette, Spinal, Angled, Size 1, 8 in...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

    LOCKING SCREW, FULLY THREADED 5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009

    LDR SPINE ROI-A INTERBODY FUSION DEVICE

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code MAX·June 9, 2010

    Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOMNOscreen plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 20, 2011

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 12, 2013

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    IMPLANTABLE DRUG INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·August 26, 2021

    IMPLANTABLE DRUG INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 26, 2021

    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024