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

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    EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001358·artVeneer life lower anteriors, UBIM, C2

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044322·Plier 121 Standard

    NIH™

    FDA UDI
    MEDTRONIC, INC.·00613994964465·WVN CATH 001358 10PK 5440 7 100 NIH

    NIH™

    FDA UDI
    MEDTRONIC, INC.·00763000199289·WVN CATH 001358 10PK 5440 7 100 NIH

    OPTIMUM

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975016300·

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657061636·Needle Holders, 5mm, Tapered Jaw with TC Insert...

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657062831·Biopsy Punch, 5mm with No Tooth Handle: 1358 Ax...

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657065474·Large Spoon Forceps, 10mm Handle: 1358 Axial T...

    MULTI ADJUSTABLE FACE MASK

    FDA 510(k)
    FDA Class 2 ·Dental

    AUDIOSCREENER OAE + ABR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 2, 2024

    DST SERIES EEA ORVIL 25MM DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US·Product code GAG·March 6, 2013

    CAPSURE SENSE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 25, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·February 22, 2008

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016