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

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    MINI MAXLOCK EXTREME PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964073557·Endo Carry-on Procedure Kit includes Enzymatic ...

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691028·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111018992·PLASTIC PRCDURE TRAY MED NON-P

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00811801034855·Straightened 4th Blade, 8 x 230 mm

    S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GALAXY G3 XSFT HEL 2MM X 8CM

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

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    SAGITTAL SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·May 9, 2013

    NURSE CALL CABLE

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·September 15, 2014

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQC·May 18, 2011

    HAWKONE 6FR

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MCW·July 1, 2021

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013

    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

    B125P Patient Monitor (with E-module slot option), REF 6160000-002

    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

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

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

    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