8 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYN-OPTICS #5200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BREAST BOLSTER
FDA 510(k)
FDA Class 2
·Radiology
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
FDA 510(k)
FDA Class 2
·Cardiovascular
ROTOPRONE
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH, INC·Product code IKZ·April 11, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 2, 2012
ENDOPOUCH RETRIEVER SPEC BAG
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GCJ·September 13, 2007
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015