10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
FORMATK MAGMA PLATFORM LASER
FDA Adverse Event
Injury
·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019
MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 12, 2018
FORMATK MAGMA PLATFORM
FDA Adverse Event
Malfunction
·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·August 22, 2008
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023