BPSS Affinity Wrist Fracture System

FDA registration

ORTHONOVIS, INC.·2 products·🇺🇸 United States

2.5mm FT cannulated cortex screw, pentalock, 28mm-

FDA registration

INDUSTRIAS MEDICAS SAMPEDRO S.A.S·2 products·🇨🇴 Colombia

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Synergy Health AST, LLC

FDA registration

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

SurgiCase

FDA registration

Materialise Sdn Bhd·1 product·🇲🇾 Malaysia

SurgiCase

FDA registration

MATERIALISE N.V.·1 product·🇧🇪 Belgium

SurgiCase

FDA registration

Materialise Colombia S.A.S·1 product·🇨🇴 Colombia

Synergy Health AST, SRL

FDA registration

Synergy Health AST, SRL·1 product·🇨🇷 Costa Rica

HydroSoft

FDA registration

MicroVention, Inc.·1 product·🇺🇸 United States

HyperSoft Advanced

FDA registration

Terumo Medical Canada, Inc.·1 product·🇨🇦 Canada

HydroSoft

FDA registration

MicroVention Costa Rica S.R.L.·1 product·🇨🇷 Costa Rica

Process Indicator Steam Sterilization Tape

FDA registration

W. H. Brady S. de R.L. de C.V.·1 product·🇲🇽 Mexico

Process Indicator Steam Sterilization Tape

FDA registration

Brady Mexico, S. de R.L. de C.V.·1 product·🇲🇽 Mexico

AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)

FDA 510(k)

FDA Class 2 ·Neurology

System, Telethermographic (Adjunctive Use)

FDA classification

FDA Class 1 ·System, Telethermographic (Adjunctive Use)

Plate, Fixation, Bone

FDA classification

FDA Class 2 ·Plate, Fixation, Bone

Device, Neurovascular Embolization

FDA classification

FDA Class 2 ·Device, Neurovascular Embolization