10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PNEUMO-WEDGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123083·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 100mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 17, 2013
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024