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

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

ToeTac™ 10° Hammertoe Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

12F Tri-Flow Triple Lumen Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REVOLUTION FULLFACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)