AMS FASCIAL-ANCHORING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digital Intraoral Imaging Plate System

FDA 510(k)

FDA Class 2 ·Dental

BELLA - VAC IRRIGATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ETEST MOXIFLOXACIN 0.002-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Telavancin (TLA) (0.002-32 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ArthroPlan Digital Templating Software

FDA 510(k)

FDA Class 2 ·Radiology

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ATRICURE ISOLATOR TRANSPOLAR PEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHROMID CARBA agar (CARB)

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

INVIZIA ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NANO-TICROWN

FDA 510(k)

FDA Class 2 ·Dental

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STAY WET 3 & STAY WET 3 (SA)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STAY WET 3 & STAY WET 3 (SA)

PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOLOTC RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry