CEDIA N-Acetylprocainamide Assay (NAPA)

FDA registration

Microgenics Corporation·1 product·🇺🇸 United States

CEDIA N-ACETYLPROCAINAMIDE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Enzyme Immunoassay, Procainamide

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Procainamide

Shockwave7578 (PT, SDB) - Shockwave Peripheral Intravascular Lithotripsy (IVL) System

FDA registration

Synergy Health AST, LLC·1 product·🇺🇸 United States

Shockwave Medical Lithoplasty System, Lithoplasty Generator and Connector Cable, Peripheral Lithoplasty Catheter

FDA registration

VANGUARD-EMS·1 product·🇺🇸 United States

Shockwave7578 (PT, SDB) - Shockwave Peripheral Intravascular Lithotripsy (IVL) System

FDA registration

Synergy Health AST, LLC·1 product·🇺🇸 United States

ONANON, INC

FDA registration

ONANON, INC·1 product·🇺🇸 United States

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA registration

RANDOX LABORATORIES LIMITED·3 products·🇬🇧 United Kingdom

Shockwave M5 IVL Catheter

FDA registration

SHOCKWAVE MEDICAL, INC.·1 product·🇺🇸 United States

CareFusion D.R. 203 Ltd.

FDA registration

CareFusion D.R. 203 Ltd.·1 product·🇩🇴 Dominican Republic

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

Percutaneous Catheter, Ultrasound

FDA classification

FDA Class 2 ·Percutaneous Catheter, Ultrasound

Assay, Glycosylated Hemoglobin

FDA classification

FDA Class 2 ·Assay, Glycosylated Hemoglobin