TUBING PACK, EXTRACORPOREAL, H-3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus VF ECMO Oxygenator

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus Smart ECMO Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

REFERENCE CHECK, CATALOG NUMBER-RCN-10

FDA 510(k)

FDA Class 2 ·Hematology

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

CRYOCHECK CLOT C

FDA 510(k)

FDA Class 2 ·Hematology

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·GEOPEN SUSCEPTIBILITY POWDER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·POTASSIUM PENICILLIN G DIAG SYS POWDER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN