EPi-Sense Guided Coagulation System with VisiTrax

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m STI Assay

FDA 510(k)

FDA Class 2 ·Microbiology

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Coolrail Linear Pen

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Isolator Synergy EnCapture Ablation System (EMH)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISOLATOR LINEAR PEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EPICOR ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYOCARE CARDIAC SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Isolator Multifunctional Linear Pen

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIA-PACK CA 19-9

FDA 510(k)

FDA Class 2 ·Immunology

ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NCONTACT COAGULATION SYSTEM KIT, MODEL CSK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Pre-Market Approval

FDA Class 2 ·UNIZYME(TM) ENZYMATIC CLEANER