O

FDA Filings

This page includes the latest FDA filings for O . Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Olympus Surgical Technologies America
Vizishot 2 Flex2020-03-18
O&M Halyard, Inc
AERO CHROME* Breathable Performance Surgical Gowns2020-03-16
OrthoPediatrics Corp.
Response BandLoc Spinal Fixation2020-03-16
O & M Haylard, Inc.
Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate2020-03-13
Ossio Ltd.
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant2020-03-06
Olympus Medical Systems Corp.
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR2020-03-06
OrbusNeich Medical Trading Inc.
Sapphire Ii Pro2020-03-04
Ophthalmic Labs, Inc.
Ovision Imaging System2020-03-03
Omnia Medical, LLC
Omnia Medical Trauma Screws2020-02-27
Ortho Clinical Diagnostics
VITROS BRAHMS PCT Reagent Pack And Calibrators2020-02-25
Omnia Medical, LLC
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage2020-02-21
OrthoCircle Spine
OrthoCircle Spine Pedicle Screw System2020-02-13
Olsen Insdustria De Equipamentos Odontomedicos
Infinity / Infinity Cross Flex Dental Systems2020-02-05
Optiscan Biomedical Corporation
OptiScanner® 5000 Glucose Monitoring System2020-02-05
OnLume Inc.
Asimov-MKS Imaging System2020-01-17
Osseus Fusion Systems
Black Diamond Navigation Instruments2020-01-17
Olympus Medical Systems Corp.
Evis Exera III Duodenovideoscope Olympus TJF-Q190V2020-01-17
OsteoRemedies, LLC
OsteoRemedies Hip Spacer System2020-01-10
Opsens Inc.
OptoWire III2020-01-02
Optima Health Solutions International Corp.
Spinalytics2019-12-21
ONTEX BVBA
Unscented W Long Plastic And Cardboard Applicator Tampons2019-12-20
Ortho-Clinical Diagnostics, Inc.
Automated Blood Grouping And Antibody Test Systems2019-12-17
Olympus Medical Systems Corp.
Single Use Balloon Dilator V (with Knife)2019-12-17
O&M Halyard, Inc.
Aero Blue Performance Surgical Gowns2019-12-13
Opsens Inc
OptoMonitor2019-12-12
Outset Medical, Inc.
Tablo Hemodialysis System, Tablo Cartridge2019-12-12
Olympus Medical Systems Corp.
Single Use Aspiration Needle2019-12-10
OrthoGrid Systems Inc.
PhantomMSK Trauma2019-12-07
OSARTIS GmbH
Hi-Fatigue Bone Cement2019-12-02
OSARTIS GmbH
Hi-Fatigue G Bone Cement2019-11-27

Latest Premarket Applications

PMAManufacturerDevice NameDate
OXFORD IMMUNOTEC,LTD.
T-SPOT. TB Test2020-03-03
OBALON THERAPEUTICS, INC.
Obalon Ballon System with Navigation and Touch2020-02-11
Orthofix, Inc.
PhysioStim and SpinalStim2019-10-08
Orthofix, Inc.
CervicalStim2019-10-08
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2019-09-11
On-X Life Technologies, Inc.
On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study2019-08-15
OBALON THERAPEUTICS, INC.
Obalon Balloon System2019-08-08
OCULAR THERAPEUTICS, INC.
ReSure Sealant2019-07-25
OBALON THERAPEUTICS, INC.
Obalon Touch Dispenser2019-07-25
Orthofix, Inc.
SpinalStim2019-07-03
OBALON THERAPEUTICS, INC.
Obalon Balloon Kit, Obalon Navigation Balloon Kit, and Obalon Touch Balloon Kit2019-07-03
OBALON THERAPEUTICS, INC.
Obalon Touch Dispenser2019-07-03
Ortho-Clinical Diagnostics, Inc.
VITROS Anti-HBc IgM2019-06-19
ORTHO-CLINICAL DIAGNOSTICS
VITROS Anti-HBc2019-06-19
ORTHO-CLINICAL DIAGNOSTICS
VITROS Anti-HBe2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS HBeAg2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS Anti-HBs2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS HBsAg2019-06-19
Orthofix, Inc.
CervicalStim2019-06-18
Orthofix, Inc.
PhysioStim and SpinalStim2019-06-18
OBALON THERAPEUTICS, INC.
OBALON BALLOON SYSTEM2019-05-29
OBALON THERAPEUTICS, INC.
Obalon Navigation Balloon Kit2019-05-16
OPHTEC BV
Artisan Myopia Intraocular Lens2019-05-14
OBALON THERAPEUTICS, INC.
Obalon Touch Dispenser2019-04-26
OBALON THERAPEUTICS, INC.
Obalon Navigation Balloon Kit2019-04-12
OPHTEC USA, INC.
Capsular Tension Ring (CTR)2019-03-27
OBALON THERAPEUTICS, INC.
Obalon Balloon System with Navigation and Touch2019-03-01
On-X Life Technologies, Inc.
On-X Prosthetic Heart Valve2019-02-26
OBALON THERAPEUTICS, INC.
Obalon Balloon System2019-02-14

Latest De Novo Filings

De NovoManufacturerDevice NameDate
OraSure Technologies, Inc.
OraQuick Ebola Rapid Antigen Test2019-10-10
Oculogica, Inc.
EyeBOX2018-12-28
OVESCO ENDOSCOPY AG
RemOVE System2017-12-22
OCULEVE, INC.
Oculeve Intranasal Tear Neurostimulator Device2017-04-24

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Suction Socket Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Suction Socket Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Remote Electrode
Otto Bock Healthcare Products GmbH2020-03-27
Myo Plus trial kit
Otto Bock Healthcare Products GmbH2020-03-27
Myo Plus trial kit
Otto Bock Healthcare Products GmbH2020-03-27
Myo Cuff
Otto Bock Healthcare Products GmbH2020-03-27
Myo Cuff
Otto Bock Healthcare Products GmbH2020-03-27
Myo Cuff
Otto Bock Healthcare Products GmbH2020-03-27
Myo Cuff
Otto Bock Healthcare Products GmbH2020-03-27
Myo Cuff
Otto Bock Healthcare Products GmbH2020-03-27
ST45
OSADA ELECTRIC CO.,LTD.2020-03-27
ELEOS™
ONKOS SURGICAL, INC.2020-03-27
ELEOS™
ONKOS SURGICAL, INC.2020-03-27
ELEOS™
ONKOS SURGICAL, INC.2020-03-27
ELEOS™
ONKOS SURGICAL, INC.2020-03-27
ELEOS™
ONKOS SURGICAL, INC.2020-03-27
ELEOS™
ONKOS SURGICAL, INC.2020-03-27
ELEOS™
ONKOS SURGICAL, INC.2020-03-27

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