Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·GAS PERMEABLE REGIMEN

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTANIOUS GAS MONITOR

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·GAS PERMEABLE REGIMEN

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTANIOUS GAS MONITOR

PDT-FACE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

FDA 510(k)

FDA Class 2 ·Radiology

InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Picosecond Laser System (Model PS10-A and PS10-B)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·\EART TRAK,HART TRAK III,MAX TRAK,MAX TRAK DP,PROA

Diode laser therapy device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·GAS PERMEABLE CONTACT LENSES

IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Endobronchial Blocker Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

IVYLASER Handhold Hair Removal Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Double Lumen Endobronchial Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

Diode laser system (Night Universe; Predator)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery