MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO STAXX FX SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Threshold™ Pedicular Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

iNtuition-T1 Mapping and T2/T2* Mapping

FDA 510(k)

FDA Class 2 ·Radiology

Duo Lumbar Interbody Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

INTELLISPACE PACS 4.X

FDA 510(k)

FDA Class 2 ·Radiology

ENZYMATIC CO2 REAGENT, MODIFICATION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Responsive Arthroscopy Wedge Push-In Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

Palisade™ Pedicular Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Responsive Arthroscopy Wedge Push-In Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

Responsive Arthroscopy Suture Anchor System

FDA 510(k)

FDA Class 2 ·Orthopedic

ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700

FDA 510(k)

FDA Class 2 ·Cardiovascular

Responsive Arthroscopy Interference Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Rampart(TM) T Lumbar Interbody Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

Shadow Knotless All-Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic