TomTecImageArena

FDA registration

CANON MEDICAL INFORMATICS, INC.·1 product·🇺🇸 United States

TomTec-Arena

FDA registration

Philips Electronics Ltd·1 product·🇨🇦 Canada

TomTec-Arena

FDA registration

TOMTEC Imaging Systems GMBH·1 product·🇩🇪 Germany

CHANGE HEALTHCARE CANADA COMPANY

FDA registration

CHANGE HEALTHCARE CANADA COMPANY·1 product·🇨🇦 Canada

TOMTEC-ARENA TTA2

FDA 510(k)

FDA Class 2 ·Radiology

CULVER TOOL & ENGINEERING

FDA registration

CULVER TOOL & ENGINEERING·2 products·🇺🇸 United States

GX CORPORATION SDN BHD (Plant 2)

FDA registration

GX CORPORATION SDN BHD (Plant 2)·1 product·🇲🇾 Malaysia

GX Corporation Sdn Bhd (Specialty Plant)

FDA registration

GX Corporation Sdn Bhd (Specialty Plant)·1 product·🇲🇾 Malaysia

CapSure(R) PS Spine System

FDA registration

SPINE WAVE, INC.·2 products·🇺🇸 United States

SMART GLOVE CORPORATION SDN BHD

FDA registration

SMART GLOVE CORPORATION SDN BHD·1 product·🇲🇾 Malaysia

LSL Polymer Patient Examination Glove

FDA registration

LSL HEALTHCARE·1 product·🇺🇸 United States

Vilex Guidewire

FDA UDI

VILEX IN TENNESSEE, INC.·00841731120502·Guidewire 1.2x150mm Dbl Trocar

Vilex Guidewire

FDA UDI

VILEX IN TENNESSEE, INC.·00841731120519·Guidewire 1.2x150mm Sgl Trocar

Ophthalmic Speculum

FDA UDI

KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

Accent Buccal Tube

FDA UDI

ORMCO CORPORATION·00889989053968·ACCENT B/T 5SGL F/S NDX -22TX18 LL

IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

FDA registration

BECKMAN COULTER, INC.·2 products·🇺🇸 United States

SSP-SIMATRIX INC.

FDA registration

SSP-SIMATRIX INC.·1 product·🇺🇸 United States

MODIFICATION TO CAPSURE PS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)

FDA 510(k)

FDA Class 1 ·General Hospital

S-LIFT®

FDA UDI

SPINEFRONTIER, INC.·00190361004592·S-LIFT, SPLIT RIB, STRAIGHT, 22MM, 12X48MM