6,332 results
·
24ms
·
Sources: EU EUDAMED, US FDA
CARESIDE APTT
FDA 510(k)
FDA Class 2
·Hematology
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001200140280·Bone Screw, Self-Drilling, 4.0 mm, 28 mm
CosmoLock
FDA UDI
Kalitec Direct LLC·B073DRK0100280·Tab Breaker, Single Sided, Cosmolock MIS
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554739·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554746·
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100280·Caddie Lid, Cervical Implants, Hinged
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0100280·Caddie, 32-36mm Curved Cages
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554753·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554760·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0100280·Caddie, MIS Rods and Caps
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033554715·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710640140280·3rd TMT Joint Cut Guide, 14mm x 28mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710630140280·2nd TMT Joint Cut Guide, 14mm x 28mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710440140280·Lateral Malleolar Osteotomy Guide, 14mm x 28mm
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SHEER THIN AROMAS RED LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ANTHEM RF
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
ADVIA CENTAUR CP TROPONIN ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·March 14, 2008
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Enforcement
Class II
·Terminated·ITC-Nexus Dx·February 12, 2014