HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CT Midline

FDA 510(k)

FDA Class 2 ·General Hospital

NuBODY Skin Toning Device

FDA 510(k)

FDA Class 2 ·Neurology

TENS&EMS units (SM9109A, SM9109B)

FDA 510(k)

FDA Class 2 ·Neurology

EasyClip Xpress

FDA 510(k)

FDA Class 2 ·Orthopedic

Ambra PACS

FDA 510(k)

FDA Class 2 ·Radiology

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SOLITAIRE 2 REVASCULARIZATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Revolution External Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Golnit Nylon Monofilament Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYLK PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Trio-CT­® Triple Lumen Catheter w/ Curved Extensions

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MouthLab Vital Signs Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLITAIRE FR REVASCULARIZATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular