21 results
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7ms
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Sources: EU EUDAMED, US FDA
N Latex CDT Kit
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·September 5, 2018
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·April 29, 2020
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·June 28, 2017
Merge PACS software. The firm name on the label is Merge Healthcare.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·March 15, 2017
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
FDA Enforcement
Class II
·Terminated·Nanosphere, Inc.·October 1, 2014
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 10, 2014
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
FDA Enforcement
Class II
·Terminated·Pdg Product Design Group Inc·October 1, 2014
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
FDA Enforcement
Class II
·Terminated·DT MedTech, LLC·November 14, 2018