Sofia Lyme FIA, Sofia Lyme Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Advanced Skin Renewing Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Innomed NPWT Silicone Foam Dressing

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electronic Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

SANDBOX I, SANDBOX II, SANDBOX JR.

FDA 510(k)

FDA Class 2 ·Physical Medicine

Balloon Guiding Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Micro Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER

Photodynamic Therapy (PDT) Equipment

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DermRays Revive

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Nd: YAG Laser Therapy Systems HM-YL900

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hysteroscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Intense Pulsed Light Treatment System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery