8 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 14, 2017
BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·May 3, 2017
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 7, 2017
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
FDA Enforcement
Class III
·Terminated·Remel Inc·September 4, 2013
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
FDA Enforcement
Class III
·Terminated·Medtronic Vascular·March 5, 2014
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·November 7, 2018
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Enforcement
Class III
·Terminated·Remel Inc·December 25, 2013
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA
FDA Enforcement
Class III
·Terminated·Branan Medical Corporation·August 10, 2016