STRATASIS SLING KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COOK UROLOGICAL GRAFT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGISIS SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) STACK PERFUSION(R) DISTAL FLOW COR. DIL. CA

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYOGEN CARDIAC CRYOSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cardioblate CryoFlex Surgical Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATRICURE BIPOLAR SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEARTPORT MAZE SYSTEM: CRYOPROBE SET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery