Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Vario-Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

LATEX EXAM GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Samsung ECG App v 1.3 (ECG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESTEMP IMPLANT, ESTEMP CLEAR

FDA 510(k)

FDA Class 2 ·Dental

LATEX EXAM GLOVES(MFG: LINGSHUN INDUSCOMM LTD LIAB

FDA 510(k)

FDA Class 1 ·General Hospital

BASE IT

FDA 510(k)

FDA Class 2 ·Dental

THE BIBICURE SYS BREAST TONER

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

Sleep Apnea Feature

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE BIBICURE SYS DERMEPIL NATURAL HAIR

FDA 510(k)

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

FDA 510(k)

FDA Class 2 ·Cardiovascular

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

FDA 510(k)

FDA Class 2 ·Orthopedic

SP-CL Hip Stem and LCU Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

H-EKA 2080/Y

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 2080/E

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1080/E

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 2065/Y

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 2065/H

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1065/Y

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

H-EKA 1065/H

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries