20 results · 46ms · Sources: EU EUDAMED, US FDA

APOLLO REVISE System

FDA registration
MEDLINE INDUSTRIES, LP (Northpoint Services)·1 product·🇺🇸 United States

Viant Medical, Inc.

FDA registration
Viant Medical, Inc.·1 product·🇺🇸 United States

APOLLO ENDOSURGERY INC

FDA registration
APOLLO ENDOSURGERY INC·1 product·🇺🇸 United States

APOLLO ENDOSURGERY COSTA RICA S.R.L.

FDA registration
APOLLO ENDOSURGERY COSTA RICA S.R.L.·1 product·🇨🇷 Costa Rica

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

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

Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

FDA classification
FDA Class 2 ·Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040

FDA registration
Ortho Clinical Diagnostics, K.K.·1 product·🇯🇵 Japan

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040

FDA registration
Ortho-Clinical Diagnostics·1 product·🇬🇧 United Kingdom

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040

FDA registration
Ortho-Clinical Diagnostics European Support Center·1 product·🇫🇷 France

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040

FDA registration
Ortho Clinical Diagnostics·1 product·🇸🇬 Singapore

Sunrise system

FDA registration
SUNRISE SA·1 product·🇧🇪 Belgium

Luminopia One

FDA registration
LUMINOPIA INC·1 product·🇺🇸 United States

Genius Digital Diagnostics System with the Genius Cervical AI algorithm

FDA registration
Hologic, Inc.·1 product·🇺🇸 United States

Genius Digital Diagnostics System with the Genius Cervical AI algorithm

FDA registration
HOLOGIC, INC.·1 product·🇺🇸 United States

Sunrise Sleep Disorder Diagnostic Aid

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Luminopia One

FDA 510(k)
FDA Class 2 ·Ophthalmic

Device For Sleep Apnea Testing Based On Mandibular Movement

FDA classification
FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

Digital Therapy Device For Amblyopia

FDA classification
FDA Class 2 ·Digital Therapy Device For Amblyopia