AXIOM INF

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEDS-4-INF+

FDA 510(k)

FDA Class 2 ·Neurology

INF 4160, MODEL D-FJ27F

FDA 510(k)

FDA Class 2 ·Neurology

INTERFERENTIAL STIMULATOR MODEL INF 4150/A

FDA 510(k)

FDA Class 2 ·Neurology

INF 4160 PLUS, MODEL D-FJ31F

FDA 510(k)

FDA Class 2 ·Neurology

ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A

FDA 510(k)

FDA Class 2 ·Neurology

RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·SGP II - F CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·SGP II - F CONTACT LENS

ADG BONE PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MIAMI-SUNNY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BraidE Embolization Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

TIDI BRAND STERILIZATION WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

HANAROSTENT Benefit Biliary (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery