VIDAS TOXO IG6 ASSAY (TX6)

FDA 510(k)

FDA Class 2 ·Microbiology

285CI INFUSION PUMP, MODIFICATION

FDA 510(k)

FDA Class 2 ·General Hospital

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK MS

FDA 510(k)

FDA Class 2 ·Microbiology

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

FDA 510(k)

FDA Class 2 ·Ophthalmic

SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERAVITAL CERAMIC EAR CANAL WALL PROSTH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.

FDA 510(k)

FDA Class 2 ·Dental

ENPATH SAFETY INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLASIATEK ACTUATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT

FDA 510(k)

FDA Class 2 ·General Hospital

VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)

FDA 510(k)

FDA Class 2 ·Neurology

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,

FDA 510(k)

FDA Class 2 ·Cardiovascular

CG FUTURE ANNULOPLASTY BAND

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pounce Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular