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
Oxavita S.R.L.
Revitalair 430F2019-11-22
OraLabs, Inc.
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray2019-11-21
O & M Halyard, Inc.
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves2019-11-08
Orthodent Laboratory, Inc.
Vivid Aligners2019-11-06
Orthosoft Inc. (d/b/a Zimmer CAS)
IASSIST Knee System2019-11-05
Orthosun Co., Ltd.
Mei Ceramic Bracket2019-11-04
Okami Medical
Okami Medical LOBO Vascular Occlusion System2019-10-30
Osseus Fusion Systems
Black Diamond Pedicle Screw System2019-10-29
Ovesco Endoscopy AG
Stentfix OTSC System Set2019-10-22
Osprey Medical Inc.
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System2019-10-17
Ortho2, LLC
SmartCeph2019-10-17
Omega Medical Imaging, LLC
CS-series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield™ (ROI Assembly)2019-10-04
OMNI Life Science, Inc.
OMNI TiN Coated Apex Knee™ System2019-09-25
OrbusNeich Medical Trading Inc.
Sapphire NC Plus Coronary Dilatation Catheter2019-09-19
Orthosoft, Inc. (d/b/a Zimmer CAS)
Signature ONE System2019-08-30
Osstem Implant Co., Ltd.
T1-CS, T1-C2019-08-30
Olympus Medical Systems Corp.
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head2019-08-30
Olympus Winter & Ibe GmbH
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)2019-08-29
Oventus Manufacturing PTY LTD
O2Vent Optima2019-08-29
Omnia Medical, LLC
Omnia Medical VBR2019-08-28
Orthosoft, Inc. (d/b/a Zimmer CAS)
Efficient Care 3D Planning2019-08-23
OSW Manufacturing, LLC
OSW Aligner System2019-08-23
OsteoRemedies, LLC
REMEDY Acetabular Cup2019-08-23
Osstell AB
Osstell Beacon2019-08-22
OrthoSpin
AutoStrut2019-08-14
Osstem Implant Co., Ltd.
Bone Screw, Bone Tack2019-08-09
Olympus Surgical Technologies America
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, And Accessories)2019-08-09
OrthoPediatrics, Corp
OrthoPediatrics PediFoot Deformity Corrections System2019-08-06
Orfit Industries NV
The AIO Solution2019-08-06
Olympus Medical Systems Corp.
Single Use Cytology Brush BC-205D2019-08-02

Latest Premarket Applications

PMAManufacturerDevice NameDate
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
Orthofix, Inc.
SpinalStim2019-07-03
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
Ortho-Clinical Diagnostics, Inc.
VITROS Anti-HBs2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS HBeAg2019-06-19
ORTHO-CLINICAL DIAGNOSTICS
VITROS Anti-HBc2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator2019-06-19
ORTHO-CLINICAL DIAGNOSTICS
VITROS Anti-HBe2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS HBsAg2019-06-19
Ortho-Clinical Diagnostics, Inc.
VITROS Anti-HBc IgM2019-06-19
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
OPKO Diagnostics, LLC.
Sangia Total PSA Test2019-01-30
OBALON THERAPEUTICS, INC.
Obalon Balloon System2019-01-25

Latest De Novo Filings

De NovoManufacturerDevice NameDate
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
HTR-PEKK
OXFORD PERFORMANCE MATERIALS, INC.2019-11-27
HTR-PEKK
OXFORD PERFORMANCE MATERIALS, INC.2019-11-27
HTR-PEKK
OXFORD PERFORMANCE MATERIALS, INC.2019-11-27
HTR-PEKK
OXFORD PERFORMANCE MATERIALS, INC.2019-11-27
HTR-PEKK
OXFORD PERFORMANCE MATERIALS, INC.2019-11-27
O-Two
O-Two Medical Technologies Inc2019-11-27
O-Two
O-Two Medical Technologies Inc2019-11-27
O-Two
O-Two Medical Technologies Inc2019-11-27
O-Two
O-Two Medical Technologies Inc2019-11-27
O-Two
O-Two Medical Technologies Inc2019-11-27
Laryngoscope
orlvision GmbH2019-11-27
Depth Gauge
OCO BIOMEDICAL INC2019-11-27
WATER CONTAINER
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
Olympus
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
Olympus
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
Olympus
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
Olympus
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
Olympus
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
WATER CONTAINER (CAP AND TUBE)
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
Olympus
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
Olympus
OLYMPUS MEDICAL SYSTEMS CORP.2019-11-27
osseolink Implant
OSSEOLINK USA LLC2019-11-27
David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare)
Oculo-Plastik Inc2019-11-26
David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare), refurb.
Oculo-Plastik Inc2019-11-26
David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare)
Oculo-Plastik Inc2019-11-26
David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare), refurb
Oculo-Plastik Inc2019-11-26
SurgiTrackSM
OWENS & MINOR DISTRIBUTION, INC.2019-11-26
Oticon
Oticon A/S2019-11-25
Desmarres (10 mm) Stainless Steel Retractor for Laser (non glare)
Oculo-Plastik Inc2019-11-25
Desmarres (10 mm) Stainless Steel Retractor for Laser (non glare), refurb.
Oculo-Plastik Inc2019-11-25
Desmarres (12 mm) Stainless Steel Retractor for Laser (non glare)
Oculo-Plastik Inc2019-11-25
Desmarres (12 mm) Stainless Steel Retractor for Laser (non glare), refurb.
Oculo-Plastik Inc2019-11-25
Desmarres (14 mm) Stainless Steel Retractor for Laser (non glare)
Oculo-Plastik Inc2019-11-25
Desmarres (14 mm) Stainless Steel Retractor for Laser (non glare), refurb.
Oculo-Plastik Inc2019-11-25
Desmarres (16 mm) Stainless Steel Retractor for Laser (non glare)
Oculo-Plastik Inc2019-11-25
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