ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VISUALINE BARBITURATES DIPSTRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

Cystoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HMB32 Dialysis Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

FDA 510(k)

FDA Class 2 ·General Hospital

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Enzyme Immunoassay, Barbiturate

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Barbiturate

BIS ENGINE

FDA 510(k)

FDA Class 2 ·Neurology

BIS ENGINE

FDA 510(k)

FDA Class 2 ·Neurology

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3