VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEMPORARY LIMB SALVAGE SHUNT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Project E Beauty LED Light Therapy Mask (Model: PE730)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGLINTE ENTEROCLYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NAJA Gastrointestinal Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUAL FLEX NON-LATEX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan CMV Test