Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

Analyzer, Gas, Neon, Gaseous-Phase

FDA classification

FDA Class 2 ·Analyzer, Gas, Neon, Gaseous-Phase

Kappa, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Kappa, Fitc, Antigen, Antiserum, Control

System, Test, Her-2/Neu, Monitoring

FDA classification

FDA Class 2 ·System, Test, Her-2/Neu, Monitoring

Bracket, Ceramic, Orthodontic

FDA classification

FDA Class 2 ·Bracket, Ceramic, Orthodontic

Aquaporin-4 Autoantibody

FDA classification

FDA Class 2 ·Aquaporin-4 Autoantibody

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

FDA classification

FDA Class 2 ·Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Cpr Aid Feedback Device (No Software)

FDA classification

FDA Class 2 ·Cpr Aid Feedback Device (No Software)

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

FDA classification

FDA Class 2 ·Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

ARGOS

FDA 510(k)

FDA Class 2 ·Neurology

CIRCUMAURAL ADHESIVE REPLACEMENT

FDA 510(k)

FDA Class 2 ·Neurology

PRESSON ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

BSM- BONE SUBSTITUTE MATERIAL

FDA 510(k)

FDA Class 2 ·Neurology

TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Ceribell Instant EEG Headcap

FDA 510(k)

FDA Class 2 ·Neurology

TNS MK I STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)

FDA 510(k)

FDA Class 2 ·Neurology

EUROPA™ Navigated Instruments

FDA 510(k)

FDA Class 2 ·Neurology

M & R DISPOSABLE ELECTRODE (14200)

FDA 510(k)

FDA Class 2 ·Neurology