Diazyme Direct Enzymatic HbA1c Control Set

FDA registration

Diazyme Laboratories, Inc.·1 product·🇺🇸 United States

MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

FDA 510(k)

FDA Class 2 ·Hematology

Cable-Ready®* Cable Grip System: Greater Trochanteric Reattachment Device (GTR)

FDA registration

Pioneer Surgical Technology, Inc.·1 product·🇺🇸 United States

Restoration Modular Hip System

FDA registration

STRYKER IRELAND OSTEONICS·8 products·🇮🇪 Ireland

Synergy Health Westport Ltd

FDA registration

Synergy Health Westport Ltd·8 products·🇮🇪 Ireland

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

Assay, Glycosylated Hemoglobin

FDA classification

FDA Class 2 ·Assay, Glycosylated Hemoglobin

Inion BioRestore Synthetic Bone Graft Substitute

FDA registration

INION OY·1 product·🇫🇮 Finland

COM.TEC CELL SEPARATOR

FDA registration

FRESENIUS HEMOCARE GMBH·1 product·🇩🇪 Germany

PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601

FDA 510(k)

FDA Class 2 ·Orthopedic

BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Thin Layer Chromatography, Tricyclic Antidepressant Drugs

FDA classification

FDA Class 2 ·Thin Layer Chromatography, Tricyclic Antidepressant Drugs

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA classification

FDA Class 2 ·Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component