10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THORACIC DRAINAGE SET, ARGYLE DUAL
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517809551·Interlock II, 9x17x14mm 20°
Bioseal Inc.
FDA UDI
BIOSEAL·00630094177090·Monolith Graphite
Performa®
FDA UDI
Merit Medical Systems, Inc.·00884450000915·
CAT-A-KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FUJI IP CASSETTE TYPE PC
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 24, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 3, 2012
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH INC.·Product code LWS·May 12, 2015
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020