ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE

FDA 510(k)

FDA Class 2 ·Dental

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS

FDA 510(k)

FDA Class 2 ·Neurology

OnPoint Augmented Reality Spine System

FDA 510(k)

FDA Class 2 ·Neurology

KNEEALIGN SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

GEL MARK IV

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

FDA 510(k)

FDA Class 2 ·Ophthalmic

Wearable Breast Pump (Model S10)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GSI Novus

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERIFIX CATHETER CONNECTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100

FDA 510(k)

FDA Class 2 ·Anesthesiology

Proficient® Posterior Cervical Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

GEL MARK III BIOPSY SITE MARKER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PICCOLO CHLORIDE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

SYNERGY TISSUE MATRIX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SENORX BIOPSY DEVICE II

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT

FDA 510(k)

FDA Class 2 ·General Hospital