SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON SYSTEMS AMMONIA REAGENT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204657·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204671·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204633·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204640·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204664·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204688·Endoscopic Biliary Endoprosthesis

COREPASS Modular Microcatheter

FDA registration

ORBUSNEICH MEDICAL CO. LTD (HONG KONG)·1 product·🇭🇰 Hong Kong

Teleport Microcatheter

FDA registration

ORBUSNEICH MEDICAL CO. LTD (HONG KONG)·1 product·🇭🇰 Hong Kong

Sapphire NC 24 Coronary Dilatation Catheter

FDA registration

ORBUSNEICH MEDICAL CO. LTD (HONG KONG)·1 product·🇭🇰 Hong Kong

Jade PTA Balloon Dilatation Catheter

FDA registration

ORBUSNEICH MEDICAL CO. LTD (HONG KONG)·1 product·🇭🇰 Hong Kong