Accessories, Soft Lens Products

FDA Pre-Market Approval

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

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

FDA 510(k)

FDA Class 2 ·Cardiovascular

ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

WEBSTER DUO-DECAPOLAR CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAD/CAMouflage Milling Block

FDA 510(k)

FDA Class 2 ·Dental

SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

FDA 510(k)

FDA Class 2 ·Cardiovascular

ETEST MOXIFLOXACIN 0.002-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Microbiology

Delta 3300

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Microbiology

REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHROMID CARBA agar (CARB)

FDA 510(k)

FDA Class 2 ·Microbiology

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

Medline ReNewal Reprocessed Stryker SERF AS Energy Probes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

FDA 510(k)

FDA Class 2 ·Radiology

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

FDA 510(k)

FDA Class 2 ·Orthopedic

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular