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
Orthocon, Inc.
Hbp6 Settable, Resorbable Hemostatic Bone Paste2020-03-27
OrthoPediatrics, Corp
Response™ Spine System, Response™ 4.5/5.0 Spine System, Response™ 5.5/6.0 Spine System2020-03-24
Open Implants, LLC
Sherlock2020-03-24
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

Latest Premarket Applications

PMAManufacturerDevice NameDate
Orthofix, Inc.
SpinalStim2020-03-27
OXFORD IMMUNOTEC,LTD.
T-SPOT. TB Test2020-03-03
OBALON THERAPEUTICS, INC.
Obalon Ballon System with Navigation and Touch2020-02-11
Orthofix, Inc.
CervicalStim2019-10-08
Orthofix, Inc.
PhysioStim and SpinalStim2019-10-08
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
OBALON THERAPEUTICS, INC.
Obalon Touch Dispenser2019-07-03
OBALON THERAPEUTICS, INC.
Obalon Balloon Kit, Obalon Navigation Balloon Kit, and Obalon Touch Balloon Kit2019-07-03
Orthofix, Inc.
SpinalStim2019-07-03
Ortho-Clinical Diagnostics, Inc.
VITROS Anti-HBc IgM2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS Anti-HBs2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS HBeAg2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS HBsAg2019-06-19
ORTHO-CLINICAL DIAGNOSTICS
VITROS Anti-HBe2019-06-19
ORTHO-CLINICAL DIAGNOSTICS
VITROS Anti-HBc2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator2019-06-19
Orthofix, Inc.
PhysioStim and SpinalStim2019-06-18
Orthofix, Inc.
CervicalStim2019-06-18
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

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
Ventline
ORIDION MEDICAL 1987 LTD.2020-04-01
Ventline
ORIDION MEDICAL 1987 LTD.2020-04-01
Sureline
ORIDION MEDICAL 1987 LTD.2020-04-01
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2020-03-31
Oxus / GCE
OXUS AMERICA, INC.2020-03-30
Oxus / GCE
OXUS AMERICA, INC.2020-03-30
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

Notice: Undefined variable: data in /var/www/fda.report/company.php on line 145

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.