ARC-EX System

FDA 510(k)

FDA Class 2 ·Physical Medicine

Annabella Double Breast Pump (ADO-US23-1000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENDOSCOPIC PLICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NAVILAS LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NAVILAS LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NAVILAS Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

FDA 510(k)

FDA Class 1 ·General Hospital

Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs

FDA 510(k)

FDA Class 1 ·General Hospital

CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Veloxion System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SNOAR(TM) OPEN AIRWAY APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS

FDA 510(k)

FDA Class 2 ·Hematology

PATHIAM IMAGING SOFTWARE FOR HER2/NEU

FDA 510(k)

FDA Class 2 ·Hematology

SwiftMR

FDA 510(k)

FDA Class 2 ·Radiology