Monarch eTNS System

FDA 510(k)

FDA Class 2 ·Neurology

KINAMED CTN STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CT/N-II SCANNER SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

OPUS TROPONIN I (CTN) TEST MODULES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TITANIUM CANNULATED TIBIAL NAIL (TI CTN)

FDA 510(k)

FDA Class 2 ·Orthopedic

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MALDI Biotyper CA System

FDA 510(k)

FDA Class 2 ·Microbiology

DIGICELL 300 SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

LISA Laser Surgical Fibers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

OmniGuide RFID Surgical Laser Fibers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGICELL 500

FDA 510(k)

FDA Class 2 ·Hematology

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)

FDA 510(k)

FDA Class 2 ·Hematology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST

Rotium Bioresorbable Wick

FDA 510(k)

FDA Class 2 ·Orthopedic

MULTI-STRIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Octane Mechanical Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPAD

FDA 510(k)

FDA Class 2 ·Physical Medicine

LASER 20

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medi Lift Mask

FDA 510(k)

FDA Class 2 ·Neurology