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

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    VIPER F2 FACET FIXATION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·February 27, 2026

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code NDL·February 22, 2026

    Endeavour MD

    FDA UDI
    METREX RESEARCH, LLC·00615375013403·FINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, NORTH AM...

    ASPIRATING SPECULUM

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896072244·ASPIRATING SPECULUM SOLID BLADE TITANIUM

    Palatal Expander2 Appliance

    FDA UDI
    Ortho Organizers, Inc.·00190707064228·Nitanium® Palatal Expander2 Appliance (28mm)

    PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-WAVE; POUR-PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    SORIN C5 SYSTEM WITH MAST ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·April 26, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 19, 2014

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    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

    B125M Patient Monitor, REF 6160000-005-XXXXXXX

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    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 L211 PROPONENT DR SL MRI Pacemaker

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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021