6,332 results · 24ms · Sources: EU EUDAMED, US FDA

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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