210 results · 21ms · Sources: EU EUDAMED, US FDA

PTK PLUS. HOME PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PTK HEALTHCHECK PREGNANCY TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TSH-CTK-3 IRMA

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CARPAL ENGAGING WRIST FUSION PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CLIMAX

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Laser, Ophthalmic

FDA Pre-Market Approval
FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval
FDA Class 2 ·HYPERION LTK SYSTEM

INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

A.S.D. SAFETY TROCAR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Samsung ECG App v 1.3 (ECG)

FDA 510(k)
FDA Class 2 ·Cardiovascular

INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ESTEMP IMPLANT, ESTEMP CLEAR

FDA 510(k)
FDA Class 2 ·Dental

BASE IT

FDA 510(k)
FDA Class 2 ·Dental

INVIGRA

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Sleep Apnea Feature

FDA 510(k)
FDA Class 2 ·Anesthesiology

INVIGRA

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

FDA 510(k)
FDA Class 2 ·Cardiovascular