136 results · 17ms · Sources: EU EUDAMED, US FDA

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Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table.

FDA Recall
Terminated ·Mallinckrodt Inc·Product code IZO·June 14, 2010

Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems. General-purpose radiographic system component used to suspend the system's image monitor.

FDA Recall
Terminated ·GE Healthcare·Product code IZO·March 9, 2007

BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radiography.

FDA Recall
Terminated ·Philips Healthcare Inc.·Product code IZO·January 17, 2011

Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.

FDA Recall
Terminated ·Shimadzu Medical Systems·Product code IZO·November 20, 2016

Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN

FDA Recall
Terminated ·Sedecal USA, Inc.·Product code IZO--·September 26, 2002

RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

FDA Recall
Open, Classified ·Eizo Corporation Eizo Kabu Hakusan Japan·Product code PGY·July 30, 2019

RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

FDA Recall
Open, Classified ·Eizo Corporation Eizo Kabu Hakusan Japan·Product code PGY·July 30, 2019

DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

EDI BZO Uncut Sheet - Cup*, Item No. 160170

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

BZO Strip Dip Card (300ng/ml)*, Item No. 100170

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

FDA Recall
Terminated ·Ino Therapeutics·Product code MRN·November 30, 2010

ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

FDA Recall
Terminated ·Ameditech Inc·Product code DKC·August 18, 2020

ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

1 Step 12 Panel Cup, Item No. NBCA-12M-W

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015