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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FNG·February 20, 2008

    STAR S4 IR Excimer Laser System; Software Version 5.15 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.22 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.00 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.01 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.02 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.10 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.30 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    STAR S4 IR Excimer Laser System; Software Version 5.20 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED

    FDA Recall
    Terminated ·Brainlab AG Kapellenstrasse 12 Feldkirchen Germany·Product code IYE·February 24, 2014

    IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·September 28, 2004

    Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·December 17, 2012

    Animas IR 1250 (1200 plus) Intended use:deliver insulin therapy

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·March 18, 2010

    Animas IR 1200 Intended use:deliver insulin therapy

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·March 18, 2010

    VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DCK·July 28, 2004

    DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code IMB·June 22, 2007

    Animas IR 1250 Insulin Pump.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·April 11, 2005