PEERSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,

FDA 510(k)

FDA Class 2 ·Orthopedic

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

FDA 510(k)

FDA Class 2 ·General Hospital

Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TorqVue Low Profile Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000, MANUAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIR-CUSHION TOCOTONOMETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FETASCAN 1500

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FIRST MEDIC MODEL 610P

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology