DELTEX MEDICAL CARDIOQ EDM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Scope ProTech

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

Diode laser therapy device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Climax Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VENA CAVA FILTER SYSTEMS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST

FDA 510(k)

FDA Class 2 ·Cardiovascular

WELLCOGEN BACTERIAL ANTIGEN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reprocessed Halo XP Diagnostic Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FREEDOM CONSTRAINED LINERS

FDA 510(k)

FDA Class 2 ·Orthopedic

WILLCOGEN MENINGITIDIS KIT ZL25

FDA 510(k)

FDA Class 2 ·Microbiology

OLYMPUS BF TYPE UC160-OL8

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Dental

Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OLYMPUS STERILIZATION TRAYS

FDA 510(k)

FDA Class 2 ·General Hospital

GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology