QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls

FDA 510(k)

FDA Class 2 ·Immunology

ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

BowTie™ SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTAL RADIO-ULNAR JOINT IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS

FDA 510(k)

FDA Class 2 ·Dental

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

FDA 510(k)

FDA Class 2 ·Dental

ri-former Predictive Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBB SPINAL ELEVATORS

FDA 510(k)

FDA Class 2 ·Orthopedic

MTS Doxycycline 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Cranial COVER

FDA 510(k)

FDA Class 2 ·Neurology

Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology