JJY Instrumentation Lab GEM Crit Check Control

FDA registration

BIONOSTICS, INC.·3 products·🇺🇸 United States

IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Power Temp(TM) Temporary Cement

FDA registration

J. MORITA USA, INC.·1 product·🇺🇸 United States

DataCal Calibrator Reference Serum

FDA registration

Fisher Diagnostics·1 product·🇺🇸 United States

Corneal Trephine

FDA UDI

KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

Recording Electrode

FDA registration

Nypro Inc (Maple Grove)·1 product·🇺🇸 United States

Auto*Therm 395

FDA registration

METTLER ELECTRONICS CORP.·1 product·🇺🇸 United States

MODIFICATION TO: LONG LENGTH GAMMA NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

FDA 510(k)

FDA Class 2 ·Orthopedic

Glucose Oxidase, Glucose

FDA classification

FDA Class 2 ·Glucose Oxidase, Glucose

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

FDA classification

FDA Class 2 ·Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Rod, Fixation, Intramedullary And Accessories

FDA classification

FDA Class 2 ·Rod, Fixation, Intramedullary And Accessories