Aerus Medical Guardian,model F170A

FDA 510(k)

FDA Class 2 ·General Hospital

PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES

FDA 510(k)

FDA Class 2 ·Hematology

ERECTION INDUCER DEVICE (EID)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)

FDA 510(k)

FDA Class 2 ·Anesthesiology

FACTOR VIII RELATED ANTIGEN ROCKET EID

FDA 510(k)

FDA Class 2 ·Hematology

BIOPOOL PROTEIN C EID KIT AND BULK PLATES

FDA 510(k)

FDA Class 2 ·Hematology

PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357

FDA 510(k)

FDA Class 2 ·Hematology

PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359

FDA 510(k)

FDA Class 2 ·Hematology

PEDIATRIC INGESTASCAN

FDA 510(k)

FDA Class 2 ·Ophthalmic

Elecsys AMH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Tg II

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM