CardioLogs ECG Analysis Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

S575 INTRAORAL DOCKING DENTAL CAMERA

FDA 510(k)

FDA Class 1 ·Dental

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IDCAM Dental Implants

FDA 510(k)

FDA Class 2 ·Dental

EndoNaut

FDA 510(k)

FDA Class 2 ·Radiology

Withings Sleep Rx

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

ExactechGPS Total Shoulder Application, Equinoxe Planning Software

FDA 510(k)

FDA Class 2 ·Neurology

PIEZOTOME M+, PIEZOTOME M+ Handpiece

FDA 510(k)

FDA Class 2 ·Orthopedic

Activ Ankle

FDA 510(k)

FDA Class 2 ·Orthopedic

CINA

FDA 510(k)

FDA Class 2 ·Radiology

SC Medica FFX

FDA 510(k)

FDA Unclassified ·Unknown

EmboCube Embolization Gelatin

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODAK 9500

FDA 510(k)

FDA Class 2 ·Dental

Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CTLH IMPORT[FR]

Importer

🇫🇷 France

MODELLING LIQUID

Basic UDI-DI

EU MDR · Eu Md Class 1 ·HUZUR DENTAL TIBBİ ÜRÜNLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ·2 devices

MGI Tech FR, SARL

Importer

🇫🇷 France

Device, Intrauterine, Contraceptive And Introducer

FDA classification

FDA Class 3 ·Device, Intrauterine, Contraceptive And Introducer

Cancer Antigen 125(CLIA)、CA125 Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices