14 results
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21ms
·
Sources: EU EUDAMED, US FDA
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
FDA 510(k)
FDA Class 2
·General Hospital
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032447·HEAD DRAPE
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00810019801006·Drape, Head
ELMED
FDA UDI
ELMED INCORPORATED·00842180188297·DeBakey-Cooley cardiovascular forceps, Longitud...
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981325671·Medial Blade, Thin, 75-115mm
JBAIDS INFLUENZA A&B DETECTION KIT
FDA 510(k)
FDA Class 2
·Microbiology
LTFS230
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXPRESS VASCULAR SD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code FGE·April 26, 2007
PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·August 29, 2016
SCEPTER XC
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code DQY·December 6, 2023
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·May 14, 2013
VALIANT CAPTIVIA
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·September 26, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·May 20, 2011
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024