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Data / FDA device clearances / Texas

FDA device clearances in Texas: 347 since Nov 2024

The full list. FDA device clearances for applicants in Texas: 347 rows for $17.35, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 18 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/texas, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 347 device decisions for applicants in Texas from November 12, 2024 to October 30, 2026: 145 510(k) clearances and De Novo grants and 202 PMA approvals and supplements, for 95 applicants. The newest, P190018/S050 on October 30, 2026, is Clareon Vivity Pro Extended Vision IOLs from Alcon Laboratories, LLC.

The request: Every new FDA device clearance or approval for a company in Texas, with its address, the device and the product code. $10 of credit on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

  • 347Decisions
  • 145510(k) and De Novo
  • 202PMA
  • October 30, 2026Latest decision

Newest decisions

The newest 100 of 347, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 30, 2026P190018/S050Clareon Vivity Pro Extended Vision IOLsAlcon Laboratories, LLCTexasApprovedPMA 180-day supplementPOEaccessdata.fda.gov
October 30, 2026P160035/S054EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.TexasApprovedPMA 135-day supplementDSQaccessdata.fda.gov
October 30, 2026P140009/S144Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
October 30, 2026P140009/S142Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) ChargerAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
October 30, 2026P010032/S266Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
October 30, 2026P010032/S264Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) ChargerAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
October 28, 2026P160035/S061EXCOR Pediatric VADBerlin Heart, Inc.Texas30-day notice acceptedPMA 30-day noticeDSQaccessdata.fda.gov
October 28, 2026P150004/S101Dorsal Root Ganglion Stimulation (DRG) EPGAbbott MedicalTexas30-day notice acceptedPMA 30-day noticePMPaccessdata.fda.gov
October 28, 2026P140009/S141Deep Brain Stimulation (DBS) EPGAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
October 28, 2026P010032/S262Spinal Cord Stimulation (SCS) External Pulse Generator (EPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
October 27, 2026P140009/S143Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse GeneratorAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
October 27, 2026P010032/S265Eterna Spinal Cord Stimulation (SCS) Implantable Pulse GeneratorAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
October 26, 2026K262276CyperusContrario Medical, Inc.TexasSubstantially Equivalent510(k) traditionalMQKaccessdata.fda.gov
October 23, 2026P160035/S060EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.Texas30-day notice acceptedPMA 30-day noticeDSQaccessdata.fda.gov
October 23, 2026K260640Kinetic Software LibraryMonebo Technologies, Inc.TexasSubstantially Equivalent510(k) traditionalDPSaccessdata.fda.gov
October 21, 2026K261347DASH Flu A/B TestNuclein, LLCTexasSubstantially EquivalentDe Novo (dual track)OCCaccessdata.fda.gov
October 16, 2026K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med CorporationTexasSubstantially Equivalent510(k) traditionalDQXaccessdata.fda.gov
October 14, 2026P160035/S056EXCOR Pediatric VADBerlin Heart, Inc.TexasApprovedPMA 135-day supplementDSQaccessdata.fda.gov
October 14, 2026K261961Ntegrate Threaded Nail SystemNvision Biomedical TechnologiesTexasSubstantially Equivalent510(k) traditionalHWCaccessdata.fda.gov
October 5, 2026K260005MyoVista wavECG (DG-200-B15-003)HeartSciences, Inc.TexasSubstantially Equivalent510(k) traditionalDPSaccessdata.fda.gov
October 2, 2026P970003/S254VNS Therapy® SystemLivaNova USA, Inc.TexasApprovedPMA real-time process supplementLYJaccessdata.fda.gov
October 2, 2026K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P.TexasSubstantially Equivalent510(k) specialPHXaccessdata.fda.gov
October 1, 2026P890047/S072PROVISC™ Ophthalmic Viscosurgical DeviceAlcon Research, Ltd.Texas30-day notice acceptedPMA 30-day noticeLZPaccessdata.fda.gov
October 1, 2026P840064/S094VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscosurgical System; DISCOVISC™ Ophthalmic...Alcon LaboratoriesTexas30-day notice acceptedPMA 30-day noticeLZPaccessdata.fda.gov
October 1, 2026P160035/S057EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.TexasApprovedPMA 135-day supplementDSQaccessdata.fda.gov
September 29, 2026DEN260007SmartRead(TM) Medical Device Identifier (4100)BridgeSource Medical CorporationTexasUnknownDe NovoSJJaccessdata.fda.gov
September 25, 2026K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCTexasSubstantially Equivalent510(k) traditionalJOJaccessdata.fda.gov
September 23, 2026P150004/S100Proclaim DRG IPGAbbott MedicalTexasApprovedPMA real-time process supplementPMPaccessdata.fda.gov
September 23, 2026P140009/S139Infinity DBS IPGAbbott MedicalTexasApprovedPMA real-time process supplementMHYaccessdata.fda.gov
September 23, 2026P010032/S260Proclaim family of SCS IPGAbbott MedicalTexasApprovedPMA real-time process supplementLGWaccessdata.fda.gov
September 18, 2026P010032/S251Quattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead ExtensionsAbbott MedicalTexasApprovedPMA 135-day supplementLGWaccessdata.fda.gov
September 18, 2026K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesTexasSubstantially Equivalent510(k) specialHRSaccessdata.fda.gov
September 16, 2026P210007/S015Vivistim® SystemMobia Medical, Inc.Texas30-day notice acceptedPMA 30-day noticeQPYaccessdata.fda.gov
September 16, 2026K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCTexasSubstantially Equivalent510(k) traditionalIYEaccessdata.fda.gov
September 11, 2026P140009/S140Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) ChargerAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
September 11, 2026P010032/S261Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) ChargerAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
September 11, 2026K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.TexasSubstantially Equivalent510(k) traditionalMQVaccessdata.fda.gov
September 9, 2026K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and...Maxter Healthcare, Inc.TexasSubstantially Equivalent510(k) traditionalLZAaccessdata.fda.gov
September 4, 2026K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.TexasSubstantially Equivalent510(k) traditionalKIFaccessdata.fda.gov
September 3, 2026K254000Happy Health Blood Pressure MonitorHappy Health, Inc.TexasSubstantially Equivalent510(k) traditionalDXNaccessdata.fda.gov
September 2, 2026K262364Ellian Enigma RF DeviceEllian CorpTexasSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
September 1, 2026P160035/S058EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.TexasApprovedPMA 180-day supplementDSQaccessdata.fda.gov
August 26, 2026K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.TexasSubstantially Equivalent510(k) specialODPaccessdata.fda.gov
August 21, 2026K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCTexasSubstantially Equivalent510(k) traditionalOVEaccessdata.fda.gov
August 20, 2026DEN250043Qoramatic Automated Stool ManagementCm Technologies, Inc.TexasUnknownDe NovoSJBaccessdata.fda.gov
August 17, 2026P190018/S051Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System, Clareon...Alcon Laboratories, LLCTexasApprovedPMA 180-day supplementHQLaccessdata.fda.gov
August 12, 2026P970003/S249VNS Therapy SystemLivaNova USA, Inc.TexasApprovedPMA 180-day supplementLYJaccessdata.fda.gov
August 12, 2026K260944ManaCold Compression SystemManamed, LLCTexasSubstantially Equivalent510(k) traditionalIRPaccessdata.fda.gov
August 11, 2026K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCTexasSubstantially Equivalent510(k) traditionalFROaccessdata.fda.gov
August 7, 2026P140009/S133Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)Abbott MedicalTexasApprovedPMA real-time process supplementMHYaccessdata.fda.gov
August 7, 2026P010032/S254Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott MedicalTexasApprovedPMA real-time process supplementLGWaccessdata.fda.gov
August 5, 2026P160035/S059EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.Texas30-day notice acceptedPMA 30-day noticeDSQaccessdata.fda.gov
August 4, 2026P890047/S070PROVISC Ophthalmic Viscosurgical DeviceAlcon Research, Ltd.TexasApprovedPMA 180-day supplementLZPaccessdata.fda.gov
August 4, 2026P840064/S092VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System.Alcon LaboratoriesTexasApprovedPMA 180-day supplementLZPaccessdata.fda.gov
July 31, 2026K261912SnØreNegatØrDnB Innovations, LLCTexasSubstantially Equivalent510(k) traditionalLRKaccessdata.fda.gov
July 31, 2026K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)TexasSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
July 30, 2026K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsTexasSubstantially Equivalent510(k) traditionalCCLaccessdata.fda.gov
July 26, 2026P150004/S099Dorsal Root Ganglion (DRG) IPGAbbott MedicalTexas30-day notice acceptedPMA 30-day noticePMPaccessdata.fda.gov
July 26, 2026P140009/S138Deep Brain Stimulation (DBS) IPGAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
July 26, 2026P010032/S259Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
July 22, 2026K262094E3D™-C Interbody SystemEvolution SpineTexasSubstantially Equivalent510(k) specialOVEaccessdata.fda.gov
July 17, 2026P140009/S134Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
July 17, 2026P010032/S255Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
July 9, 2026K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCTexasSubstantially Equivalent510(k) traditionalDQKaccessdata.fda.gov
July 8, 2026P930014/S164AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc.Texas30-day notice acceptedPMA 30-day noticeHQLaccessdata.fda.gov
July 8, 2026K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCTexasSubstantially Equivalent510(k) specialODPaccessdata.fda.gov
July 8, 2026K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)TexasSubstantially Equivalent510(k) traditionalQFMaccessdata.fda.gov
July 6, 2026P930014/S163Acrosof Posterior Chamber Intraocular LensAlcon Laboratories, Inc.Texas30-day notice acceptedPMA 30-day noticeHQLaccessdata.fda.gov
July 6, 2026P190018/S053Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic...Alcon Laboratories, LLCTexas30-day notice acceptedPMA 30-day noticeHQLaccessdata.fda.gov
July 6, 2026P040020/S120AcrySof ReSTOR® Apodized Diffractive Optic Posterior Chamber IOLAlcon Research, Ltd.Texas30-day notice acceptedPMA 30-day noticeMFKaccessdata.fda.gov
July 6, 2026K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.TexasSubstantially Equivalent510(k) traditionalNUCaccessdata.fda.gov
July 2, 2026P930014/S165AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc.Texas30-day notice acceptedPMA 30-day noticeHQLaccessdata.fda.gov
July 2, 2026P190018/S054Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic...Alcon Laboratories, LLCTexas30-day notice acceptedPMA 30-day noticeHQLaccessdata.fda.gov
July 2, 2026P190018/S052Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic...Alcon Laboratories, LLCTexas30-day notice acceptedPMA 30-day noticeHQLaccessdata.fda.gov
July 2, 2026P140009/S132Liberta RC™ Deep Brain Stimulation (DBS) IPGAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov
July 2, 2026P040020/S121AcrySof® IQ ReSTOR® Posterior Chamber Intraocular LensesAlcon Research, Ltd.Texas30-day notice acceptedPMA 30-day noticeMFKaccessdata.fda.gov
July 2, 2026P040020/S119AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOLAlcon Research, Ltd.Texas30-day notice acceptedPMA 30-day noticeMFKaccessdata.fda.gov
July 2, 2026P010032/S253Etema™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
June 30, 2026P150004/S095Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)Abbott MedicalTexasApprovedPMA real-time process supplementPMPaccessdata.fda.gov
June 24, 2026K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc.TexasSubstantially Equivalent510(k) traditionalaccessdata.fda.gov
June 18, 2026P250013/S002aura6000™ systemLivaNova USA, Inc.TexasApprovedPMA 180-day supplementMNQaccessdata.fda.gov
June 18, 2026P210007/S014Vivistim Pair VNS SystemMobia Medical, Inc.Texas30-day notice acceptedPMA 30-day noticeQPYaccessdata.fda.gov
June 18, 2026K253050RadOncAIInformaiTexasSubstantially Equivalent510(k) traditionalMUJaccessdata.fda.gov
June 12, 2026K261366VirtusSomnomed, Inc.TexasSubstantially Equivalent510(k) specialLRKaccessdata.fda.gov
June 11, 2026K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield...FloShield, Inc.TexasSubstantially Equivalent510(k) traditionalGCJaccessdata.fda.gov
June 4, 2026P170034/S018Hydrus® MicrostentAlcon Research, LLCTexas30-day notice acceptedPMA 30-day noticeOGOaccessdata.fda.gov
June 4, 2026K253994TroKit Laparoscope Lens WiperTroCare, LLCTexasSubstantially Equivalent510(k) traditionalGCJaccessdata.fda.gov
May 29, 2026P010019/S087FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSESAlcon Laboratories, Inc.Texas30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
May 26, 2026P010032/S252Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott MedicalTexas30-day notice acceptedPMA 30-day noticeLGWaccessdata.fda.gov
May 21, 2026DEN250028DeepView AI® SystemSpectralmd, Inc.TexasUnknownDe NovoSHYaccessdata.fda.gov
May 15, 2026P260004Signatera™ CDxNatera, Inc.TexasApprovedPMA original approvalPQPaccessdata.fda.gov
May 15, 2026P190018/S046Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)Alcon Laboratories, LLCTexasApprovedPMA 180-day supplementHQLaccessdata.fda.gov
May 8, 2026K260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCTexasSubstantially Equivalent510(k) traditionalIYEaccessdata.fda.gov
May 4, 2026K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)TexasSubstantially Equivalent510(k) traditionalQFMaccessdata.fda.gov
May 1, 2026K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.TexasSubstantially Equivalent510(k) traditionalPKCaccessdata.fda.gov
April 30, 2026P930014/S161AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL...Alcon Laboratories, Inc.TexasApprovedPMA 180-day supplementHQLaccessdata.fda.gov
April 30, 2026P250013/S001aura6000™ systemLivaNova USA, Inc.TexasApprovedPMA 180-day supplementMNQaccessdata.fda.gov
April 30, 2026P190018/S048Clareon Aspheric Hydrophobic Acrylic IOL (SY60WF); Clareon Aspheric UV Absorbing IOL (CC60WF); Clareon Toric...Alcon Laboratories, LLCTexasApprovedPMA 180-day supplementHQLaccessdata.fda.gov
April 30, 2026P150004/S094Proclaim™ Dorsal Root Ganglion (DRG) IPGAbbott MedicalTexas30-day notice acceptedPMA 30-day noticePMPaccessdata.fda.gov
April 30, 2026P140009/S131Infinity™ Deep Brain Stimulation (DBS) IPG; Liberta RC™ DBS IPGAbbott MedicalTexas30-day notice acceptedPMA 30-day noticeMHYaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Abbott Medical99October 30, 2026
Alcon Laboratories, Inc.25July 8, 2026
Alcon Laboratories, LLC16October 30, 2026
Berlin Heart, Inc.15October 30, 2026
Alcon Research, Ltd.15October 1, 2026
LivaNova USA, Inc.13October 2, 2026
Mobia Medical, Inc.11September 16, 2026
Encore Medical L.P.9October 2, 2026
Healgen Scientific,, LLC7April 13, 2026
Alcon Laboratories6October 1, 2026
Alcon Research, LLC5June 4, 2026
Nvision Biomedical Technologies, Inc.5April 1, 2026
Phasor Health, LLC5November 21, 2025
Nvision Biomedical Technologies4October 14, 2026
Argon Medical Devices, Inc.4February 23, 2026
Neurocareai, Inc. (Dba Savelife.Ai)3July 31, 2026
Evolution Spine3July 22, 2026
Medcad3March 27, 2026
Astura Medical3January 22, 2026
Acuity Surgical Devices, LLC3July 30, 2025

By panel

PanelDecisionsLatest
Neurology122October 30, 2026
Ophthalmic67October 30, 2026
Orthopedic54October 14, 2026
Cardiovascular26October 30, 2026
Radiology13September 16, 2026
Physical Medicine12September 16, 2026
General, Plastic Surgery10September 2, 2026
Gastroenterology, Urology8August 20, 2026
Dental7September 4, 2026
Anesthesiology5July 30, 2026
Clinical Toxicology5March 16, 2026
Obstetrics/Gynecology4October 26, 2026
General Hospital4September 25, 2026
Microbiology3October 21, 2026
Unknown3August 11, 2026
Ear, Nose, Throat2April 26, 2026
Pathology1May 15, 2026
Clinical Chemistry1December 23, 2025

By decision type

Decision typeDecisionsLatest
PMA 30-day notice116October 30, 2026
510(k) traditional114October 26, 2026
PMA real-time process supplement39October 2, 2026
PMA 180-day supplement35October 30, 2026
510(k) special23October 2, 2026
PMA 135-day supplement5October 30, 2026
De Novo5September 29, 2026
PMA special supplement4April 25, 2026
De Novo (dual track)2October 21, 2026
PMA original approval2May 15, 2026
510(k) abbreviated1November 6, 2025
PMA panel track supplement1March 5, 2025

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.