HEARTFLOW FFRCT

FDA 510(k)

FDA Class 2 ·Cardiovascular

AKCESS-CATH KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIGHT ATRIAL CATHETER KITS

FDA 510(k)

FDA Class 2 ·Cardiovascular

REFRACTEC MCS-100

FDA 510(k)

FDA Class 2 ·Ophthalmic

3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH

FDA 510(k)

FDA Class 2 ·General Hospital

BEAR (Bridge-Enhanced ACL Repair) Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

da Vinci SP Surgical System (SP1098)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING

FDA 510(k)

FDA Class 3 ·Cardiovascular

BAROnova Insufflation System, BAROnova Accessory Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ToothWave™

FDA 510(k)

FDA Class 2 ·Dental

Q-Collar

FDA 510(k)

FDA Class 2 ·Neurology

EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MASTER KIT B

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CEDIA SIROLIMUS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Luminopia One

FDA 510(k)

FDA Class 2 ·Ophthalmic

EarLens Contact Hearing Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NGARDE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PROCEDURE KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOERAE SURGICAL MARKING PEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery