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

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    FDA 510(k)
    FDA Class 2 ·Dental

    Autosoft XC

    FDA UDI
    Unomedical A/S·05705244016958·Single use infusion set for subcutaneous infusi...

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 6, 2022

    ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEIGER NEEDLE ADAPTER, MODEL 406

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

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 2, 2023

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 9, 2015

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013

    SPIDERX¿ EMBOLIC PROTECTION DEVICE

    FDA Adverse Event
    Injury ·EV3 INC.·Product code NTE·February 25, 2011

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code DXC·February 19, 2008

    TRIATHLON #4 PS INSERT 11MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·August 23, 2013

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024