12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LUX-Dx II (M302); LUX-Dx II+ (M312)
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578761·CoRoent Ant TLIF Ti, 13x11x32mm 8°
BD BBL™ Sensi-Disc™ Streptomycin 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902313282·BD BBL™ Sensi-Disc™ Streptomycin 10 µg
RECOVERY FILTER SYSTEM, MODEL RF-048F
FDA 510(k)
FDA Class 2
·Cardiovascular
Dexcom G6 Continuous Glucose Monitoring (CGM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 22, 2015
LIGASURE V SEALER/DIVIDER
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 25, 2011
QUARTET
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 17, 2013
Achieva TX Interventional Coil 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025