BEUDAMED
    1,568 results · 29ms · 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 ×

    T2 FLEXIBLE NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Malecot

    FDA UDI
    COOK INCORPORATED·00827002143586·Percutaneous Malecot Nephrostomy Set

    Non-Locking Screw, 2.4mm x 18mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026153·

    NDO SURGICAL SURGICAL OVERTUBE

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

    BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910

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

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·October 6, 2020

    11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FGB·April 1, 2022

    NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·February 8, 2018

    11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·May 18, 2022

    SCREW, ROUND DELTA TAPE- RED INTERFER 10 X 35MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·April 29, 2013

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 26, 2011

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·NORTH HAVEN - USS·Product code MFJ·July 23, 2008

    11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    ENDO-MODEL SL KNEE PROSTHESIS SYSTEM CONNECTION COMPONENT, ROTATIONAL VERSION

    FDA Adverse Event
    Injury ·WALDEMAR LINK GMBH & CO. KG·Product code KRO·November 8, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 7, 2018

    HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·August 17, 2018

    HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·May 15, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·September 6, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 11, 2018

    11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·May 18, 2022