Lumpipulse G CA19-9-N

FDA 510(k)

FDA Class 2 ·Immunology

NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EPi-Sense Guided Coagulation System with VisiTrax

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE

FDA 510(k)

FDA Class 2 ·Dental

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Isolator Multifunctional Linear Pen

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER

FDA 510(k)

FDA Class 2 ·Dental

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

OMNIgene GUT Dx

FDA 510(k)

FDA Class 2 ·Microbiology

Gili Pro BioSensor (also known as “Gili BioSensor System”)

FDA 510(k)

FDA Class 2 ·Cardiovascular