Prosthesis, Esophageal

FDA classification

FDA Class 2 ·Prosthesis, Esophageal

Bag, Polymeric Mesh, Pacemaker

FDA classification

FDA Class 1 ·Bag, Polymeric Mesh, Pacemaker

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS FOLATE ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CapnoSpot™ Pneumothorax Decompression Indicator

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VIGIL HEMOGLOBIN (HBALC) CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SYNCHRON SYSTEMS AMPHETAMINE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIGIL PROTEIN CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SYNCHRON CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAM JUNCTIONAL TOURNIQUET

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNCHRON SYSTEMS LIPID CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry