Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Harmony XL Multi-Application Platform

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNISTEP HCG PREGNANCY TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

E-FAX RECEIVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

THROMBO-SCREEN PLATELET ADHESION

FDA 510(k)

FDA Class 2 ·Hematology

THROMBO SCREEN QUANTITATIVE HEPARIN ASSA

FDA 510(k)

FDA Class 2 ·Hematology

THROMBO-CETIN (RISTOCETIN)

FDA 510(k)

FDA Class 2 ·Hematology

THROMBO-SCREEN AT-111 KIT

FDA 510(k)

FDA Class 2 ·Hematology

MANDOMETER III

FDA 510(k)

FDA Class 2 ·Neurology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

FDA 510(k)

FDA Class 2 ·Ophthalmic

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker

FDA 510(k)

FDA Class 2 ·Ophthalmic

SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Pixx2430 Digital Diagnostic X-Ray Receptor Panel

FDA 510(k)

FDA Class 2 ·Radiology

SmoothSkin BARE+

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

FDA 510(k)

FDA Class 2 ·Radiology

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

FDA 510(k)

FDA Class 2 ·Radiology