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

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

FDA classification

FDA Class 2 ·Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

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

Visby Medical Women's Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

DEKA ARM SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

ActiPatch

FDA 510(k)

FDA Class 2 ·Physical Medicine

Colibrí

FDA 510(k)

FDA Class 2 ·Microbiology

ActiPatch(R)

FDA 510(k)

FDA Class 2 ·Physical Medicine

BD Kiestra IdentifA

FDA 510(k)

FDA Class 2 ·Microbiology

BD Kiestra IdentifA

FDA 510(k)

FDA Class 2 ·Microbiology