18 results · 43ms · Sources: EU EUDAMED, US FDA

Butterfly iQ

FDA registration
BUTTERFLY NETWORK, INC.·3 products·🇺🇸 United States

BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LI

FDA registration
BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LI·3 products·🇹🇭 Thailand

Poseidon Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

MEGA SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809763500664·T-Wrench 3.0mm

Professional Defibrillator AME-2900

FDA registration
AMELIFE LLC·8 products·🇺🇸 United States

UNIMAX MEDICAL SYSTEMS INC.

FDA registration
UNIMAX MEDICAL SYSTEMS INC.·1 product·🇹🇼 Taiwan

Endo Pouches

FDA registration
TECH MEDICAL SERVICES, INC.·1 product·🇺🇸 United States

UNIMAX MEDICAL SYSTEMS INC.

FDA registration
UNIMAX MEDICAL SYSTEMS INC.·1 product·🇹🇼 Taiwan

Needle Holder

FDA UDI
KATENA PRODUCTS, INC.·00841668108314·BARRAQUER NEEDLE HOLDER STRAIGHT

Zio® AT Patch

FDA registration
IRHYTHM TECHNOLOGIES, INC.·5 products·🇺🇸 United States

DT-105 Thermometer

FDA registration
A&D ENGINEERING, INC.·1 product·🇺🇸 United States

UNIMAX SPECIMEN RETRIEVAL SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LIFEPAK 12 DEFIBRILLATOR/MONITOR

FDA 510(k)
FDA Class 3 ·Cardiovascular

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376519999·16 mm CORE ENDPLATE, LAT 16 x 35 mm 10°

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376521268·16 mm CORE ENDPLATE, BAN 16 x 35 mm 10°

System, Imaging, Pulsed Doppler, Ultrasonic

FDA classification
FDA Class 2 ·System, Imaging, Pulsed Doppler, Ultrasonic

Automated External Defibrillators (Non-Wearable)

FDA classification
FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Laparoscope, General & Plastic Surgery

FDA classification
FDA Class 2 ·Laparoscope, General & Plastic Surgery