7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
FDA 510(k)
FDA Class 2
·Cardiovascular
PPD BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
FDA 510(k)
FDA Class 2
·Dental
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE LLC.·Product code NDN·December 10, 2010
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 17, 2013
ALTRX +4 10D 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·July 8, 2014
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