BEUDAMED
    26 results · 26ms · Sources: EU EUDAMED, US FDA

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    SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964072611·Endo Carry-On Procedure Kit

    STREERABLE PTCA GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    GALAXY G3 XSFT HEL 2MM X 8CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    OSSEOTITE TAPERED CERTAIN PREVAIL MPLANT 4/3 X 10MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 26, 2022

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 26, 2022

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·May 9, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 15, 2014

    WAVELIGHT FS200 FEMTOSECOND LASER

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·May 18, 2011

    REAL INTELLIGENCE 5MM CYLINDRICAL BUR

    FDA Adverse Event
    Injury ·BLUE BELT TECHNOLOGIES·Product code OLO·April 25, 2023

    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code LRO·August 15, 2007

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    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

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number U128, VALITUDE CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021