W.O.M. LASER U100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

StatStrip Xpress 2 Glucose Hospital Meter System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

CryoGlow (FW3XXXX)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

METS MODULAR DISTAL FEMUR

FDA 510(k)

FDA Class 2 ·Orthopedic

CLOTH TENS/BNES ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS

FDA 510(k)

FDA Class 2 ·Radiology

TORNIER SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANDELA LASSER SYSTEMS MODIFIED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

FDA 510(k)

FDA Class 2 ·General Hospital

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc

FDA 510(k)

FDA Class 2 ·Orthopedic

SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EYE-SYNC

FDA 510(k)

FDA Class 2 ·Neurology

STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BUTTON REPLACEMENT GASTROSTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Omnipod 5 SmartBolus Calculator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MENTOR ADVENT A/B SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology