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

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    PERFRINGENS SUPPLEMENT A

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Preat

    FDA UDI
    Preat Corporation·00842092172636·1.8mm Retention Caps--Pink (6-Pack)

    ACUMED

    FDA UDI
    Acumed LLC·10806378040726·Awl Alignment Guide

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197418850·Deaver Retractor, large 25x127...

    L100 Go System

    FDA 510(k)
    FDA Class 2 ·Neurology

    BOHN FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIEGO CONSOLE SINUS SHAVER HANDPIECE

    FDA Adverse Event
    Other ·GYRUS ENT, LLC·Product code HRX·January 5, 2004

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·May 1, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 8, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    FDA Adverse Event
    Malfunction ·VERTIFLEX INC.·Product code NQO·February 5, 2021

    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.

    FDA Recall
    Terminated ·Allesee Orthodontic Appliances·Product code DYJ·February 24, 2014

    Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code HDW·February 26, 2013

    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

    FDA Recall
    Terminated ·Besmed Health Business Corporation No.5, Lane 116, Wu-Kong 2nd Road Wu-Ku District New Taipei City Taiwan·Product code CAE·August 9, 2018

    Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code LKF·October 31, 2012

    Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code LKF·October 31, 2012

    AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code DYJ·June 6, 2013

    LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code MQB·February 26, 2013

    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code JOR·November 2, 2010

    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code JOR·November 2, 2010