9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Klarity SRS Baseplate, Klarity Promise Baseplate
FDA 510(k)
FDA Class 2
·Radiology
ambIT*
FDA UDI
Avanos Medical, Inc.·00193494001032·ambIT* Epidural Kit
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005916·ambIT Epidural Kit
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General Hospital
TIPOWER POWERDRIVE AND RIMPOWER X & SX
FDA 510(k)
FDA Class 2
·Physical Medicine
PLATE, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·November 3, 2014
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 18, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
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