da Vinci Xi Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESCOPE 8 DEC-8108A AND DEC-8204A

FDA 510(k)

FDA Class 2 ·Cardiovascular

MECTACER BIOLOX OPTION HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP

FDA 510(k)

FDA Class 2 ·Hematology

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEARTFLOW FFRCT

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVIS EXERA III VIDEO SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTOVAC 7900 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LASER 3 SPSC300

FDA 510(k)

FDA Class 2 ·Physical Medicine

TC-PLUS POROUS FEMORAL COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

iRestore Professional 282

FDA 510(k)

FDA Class 2 ·Physical Medicine

Trevo Trak 21 Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNGO EXPERT-1

FDA 510(k)

FDA Class 2 ·Radiology

MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION

FDA 510(k)

FDA Class 2 ·Radiology

SPI SYSTEM DENTAL IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

Shoreline Cervical Interbody RT System

FDA 510(k)

FDA Class 2 ·Orthopedic

SERIES TEN THOUSAND COMPACT

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENZYGNOST ANTI-CMV IGM TEST

FDA 510(k)

FDA Class 2 ·Microbiology