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

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    BD NEXIVA CLOSED IV CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·Product code FOZ·June 25, 2021

    MEDTOX®

    FDA UDI
    MEDTOX DIAGNOSTICS, INC.·00690286000742·Positive toxicology urine control used to monit...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180178397·tangential occlusion clamp, DeBAKEY-SATINSKY, 2...

    ALL SILICONE FOLEY BALLOON CATHETER

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369400565·2way/Green 30cc 20fr

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158219472·CLAMP DEBAKEY-SATINSKY ATRAUMA TANGENTIAL OCCLU...

    Forefoot Screws

    FDA UDI
    Life Spine, Inc.·00190837019969·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450191439·

    Zavation

    FDA UDI
    Zavation LLC·00197157007461·ALIF Universal AWL, 20mm

    ROVERS SPATULA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 9, 2013

    5 MM DIAMOND BALL.

    FDA Adverse Event
    Injury ·DEPUY SYNTHES POWER TOOLS·Product code HBE·September 19, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 20, 2011

    ELECSYS IGF-1

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CFL·November 4, 2022

    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012

    TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code KWQ·May 29, 2012

    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

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·November 14, 2018