Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

RETROX

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HEM-AVERT PERIANAL STABILIZER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NUCLEUS-X PTV CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND

FDA 510(k)

FDA Class 2 ·Neurology

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

DIAMOND PROBE/PERIO 2000 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Pre-Market Approval

FDA Class 2 ·UNIZYME(TM) ENZYMATIC CLEANER

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)

FDA 510(k)

FDA Class 2 ·Neurology

SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER MX2/OTW BALLOON DILATATION CATHETER

Anti-Ss-A 52 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A 52 Autoantibodies

Anti-Ss-A Ro60 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A Ro60 Autoantibodies

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY