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

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    OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    SALTER LABS·00607411200847·High concentration partial re-breather, 7' (2.1...

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741144790·Catheter Placement Kit

    AtriCure System Cart

    FDA UDI
    ATRICURE, INC.·00818354011708·Cable Kit, Basic Cart

    Intellijoint Navigation System

    FDA UDI
    Intellijoint Surgical Inc·00628184007976·Intellijoint Navigation System, Portable System

    CORTEK CYSTOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GSI 2000 MIDDLE EAR ANALYZER

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

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 31, 2026

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 31, 2026

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·February 22, 2026

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    PRISM HIV O PLUS

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MZF·February 24, 2011

    ACHALASIA PNEUMATIC HAND PUMP AND MONITOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GBA·February 21, 2008

    4F M-I STIFFEN 40CM NT-SS (610366)

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP.·Product code DQX·January 10, 2012

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 15, 2020

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018