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

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    ELECYSYS SHBG

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814558·GENUMEDI SAND SIZE IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814725·GENUMEDI EXTRA WIDE SAND SIZE IV

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964073199·The ENDO CARRY-ON Procedure Kit contains all of...

    CRYOPEN CRYOSURGICAL SYSTEM, K102214

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

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795049421·2.8mm Cannulated Drill

    Paragon 28

    FDA UDI
    Provision·B504OMP8091028140·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837026806·PLATEAU Interbody, Curved, Bulleted, 11mm 28mm ...

    COLLAGEN NERVE CUFF

    FDA 510(k)
    FDA Class 2 ·Neurology

    DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 24, 2015

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 9, 2013

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·September 19, 2014

    ALARIS® PUMP MODULE

    FDA Adverse Event
    Injury ·CAREFUSION SD·Product code FRN·December 19, 2019

    LL100 CRYOSURGICAL

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·April 27, 2016

    ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·July 31, 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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021