EDI VERIS SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

PULSAR EM

FDA 510(k)

FDA Class 2 ·Physical Medicine

DOWNING SPECTRAL ILLUMINATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

FDA 510(k)

FDA Class 2 ·Dental

Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)

MI-328, MI-316, MI-388 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

3-Ply Disposable Medical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cold Compression Wrap Pro

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1-Step Culture Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems

FDA 510(k)

FDA Class 2 ·Dental

Hemagglutination Inhibition, Barbiturate

FDA classification

FDA Class 2 ·Hemagglutination Inhibition, Barbiturate

Photostimulator, Ac-Powered

FDA classification

FDA Class 2 ·Photostimulator, Ac-Powered

Drape, Surgical, Exempt

FDA classification

FDA Class 2 ·Drape, Surgical, Exempt