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

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    Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·January 27, 2006

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Enforcement
    Class II ·Terminated·NOX MEDICAL·October 13, 2021

    Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·June 14, 2019

    Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·June 14, 2019

    Stat Profile Critical Care Xpress CCX+ (R) Anaylzer Catalog NUmber: 37555 R= Refurbished

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Stat Profile Critical Care Xpress CCX (R) Analyzer Catalog Number: 37562 R= Refurbished

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CHL·March 30, 2004

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

    FDA Recall
    Terminated ·Liberty Medical Supplies·Product code FMF·February 24, 2003

    (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·November 11, 2020

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·April 13, 2004

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 4, 2004

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Recall
    Terminated ·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IWZ·July 16, 2014

    Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·May 4, 2011

    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    FDA Recall
    Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012