INTRAUTERINE CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STOPCOCK

FDA 510(k)

FDA Class 2 ·General Hospital

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EmbedMed

FDA 510(k)

FDA Class 2 ·Dental

EmbedMed

FDA 510(k)

FDA Class 2 ·Orthopedic

CRYOCHECK CLOT S

FDA 510(k)

FDA Class 2 ·Hematology

EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear

FDA 510(k)

FDA Class 2 ·Ophthalmic

CRYOCHECK CLOT APCR

FDA 510(k)

FDA Class 2 ·Hematology

CRYOCHECK WEAK LUPUS POSITIVE CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50

FDA 510(k)

FDA Class 2 ·Hematology

CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50

FDA 510(k)

FDA Class 2 ·Hematology

BioXmark

FDA 510(k)

FDA Class 2 ·Radiology

REFERENCE CHECK, CATALOG NUMBER-RCN-10

FDA 510(k)

FDA Class 2 ·Hematology

Hydrozid

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SKIN CARE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

FDA 510(k)

FDA Class 2 ·Hematology

CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15

FDA 510(k)

FDA Class 2 ·Hematology