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Data / FDA device clearances / Arizona

FDA device clearances in Arizona: 188 since Nov 2024

The full list. FDA device clearances for applicants in Arizona: 188 rows for $9.40, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 6 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/arizona, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 23, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 188 device decisions for applicants in Arizona from November 14, 2024 to October 23, 2026: 40 510(k) clearances and De Novo grants and 148 PMA approvals and supplements, for 33 applicants. The newest, P250050/S001 on October 23, 2026, is Liverty™ TIPS Stent Graft from Bard Peripheral Vascular, Inc..

The request: Every new FDA device clearance or approval for a company in Arizona, 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.

  • 188Decisions
  • 40510(k) and De Novo
  • 148PMA
  • October 23, 2026Latest decision

Newest decisions

The newest 100 of 188, 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 23, 2026P250050/S001Liverty™ TIPS Stent GraftBard Peripheral Vascular, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIRaccessdata.fda.gov
October 23, 2026P240037/S003VENTANA MET (SP44) RxDx AssayVentana Medical Systems, Inc. (Roche Tissue Diagnostics)ArizonaApprovedPMA 180-day supplementSERaccessdata.fda.gov
October 23, 2026K260776VENTANA MMR IHC PanelRoche Tissue Diagnostics, Inc.ArizonaSubstantially Equivalent510(k) traditionalPZJaccessdata.fda.gov
October 19, 2026K262917Reprocessed BRK Transseptal NeedleInnovative Health, LLCArizonaSubstantially Equivalent510(k) traditionalNMKaccessdata.fda.gov
October 16, 2026P240010/S007MI Cancer SeekCaris Life SciencesArizonaApprovedPMA real-time process supplementPQPaccessdata.fda.gov
October 8, 2026P210001/S016VENTANA MMR RxDx PanelVentana Medical Systems, Inc. (Roche Tissue Diagnostics)ArizonaApprovedPMA 180-day supplementQNHaccessdata.fda.gov
October 8, 2026P200019/S014VENTANA MMR RxDx PanelVentana Medical SystemsArizonaApprovedPMA 180-day supplementQNHaccessdata.fda.gov
October 8, 2026P160021/S051GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisW. L. Gore & Associates, Inc.ArizonaApprovedPMA panel track supplementPRLaccessdata.fda.gov
September 25, 2026P250050Liverty™ TIPS Stent GraftBard Peripheral Vascular, Inc.ArizonaApprovedPMA original approvalMIRaccessdata.fda.gov
September 23, 2026K261892ProRib Fixation SystemCosta Surgical, Inc.ArizonaSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
September 1, 2026K260613AMI™ Plasma Cartridge, AMI™Sequitur Health Corp.ArizonaSubstantially Equivalent510(k) traditionalJIDaccessdata.fda.gov
August 25, 2026P990081/S060PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.ArizonaApprovedPMA panel track supplementMVCaccessdata.fda.gov
August 25, 2026P190031/S016VENTANA HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.ArizonaApprovedPMA panel track supplementNYQaccessdata.fda.gov
August 19, 2026K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedArizonaSubstantially Equivalent510(k) traditionalKPOaccessdata.fda.gov
August 14, 2026K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.ArizonaSubstantially Equivalent510(k) specialKNWaccessdata.fda.gov
August 3, 2026P050006/S119GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.ArizonaApprovedPMA special supplementMLVaccessdata.fda.gov
July 31, 2026K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupArizonaSubstantially Equivalent510(k) specialMQPaccessdata.fda.gov
July 31, 2026K261809Interwedge® Standalone LateralFoundation Surgical GroupArizonaSubstantially Equivalent510(k) specialOVDaccessdata.fda.gov
July 29, 2026P200030/S026GORE® EXCLUDER® Conformable AAA EndoprosthesisW. L. Gore and Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
July 27, 2026K262474ND Needle Guidance SystemAccurate Access, LLCArizonaSubstantially Equivalent510(k) traditionalITXaccessdata.fda.gov
July 13, 2026P210032/S026GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1W. L. Gore & Associates, Inc.ArizonaApprovedPMA 180-day supplementMIHaccessdata.fda.gov
July 9, 2026P030011/S099SynCardia Temporary Total Artificial Heart (TAH-t) System – Freedom Driver SystemSyncardia Systems, LLCArizona30-day notice acceptedPMA 30-day noticeLOZaccessdata.fda.gov
July 8, 2026P200030/S025GORE® EXCLUDER® Conformable AAA EndoprosthesisW. L. Gore and Associates, Inc.ArizonaApprovedPMA real-time process supplementMIHaccessdata.fda.gov
July 8, 2026P020004/S207GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch EndoprosthesisW. L. Gore & Associates, Inc.ArizonaApprovedPMA real-time process supplementMIHaccessdata.fda.gov
July 2, 2026P240010/S010MI Cancer SeekCaris Life SciencesArizona30-day notice acceptedPMA 30-day noticePQPaccessdata.fda.gov
July 1, 2026P230023/S012GORE EXCLUDER Thoracoabdominal Branch EndoprosthesisW. L. Gore & Associates, Inc.ArizonaApprovedPMA special supplementQZKaccessdata.fda.gov
June 23, 2026P020004/S208GORE® EXCLUDER® AAA EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
June 22, 2026P130029/S015Fluency™ Plus Endovascular Stent GraftBard Peripheral Vascular, Inc.Arizona30-day notice acceptedPMA 30-day noticePFVaccessdata.fda.gov
June 18, 2026K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability SolutionsArizonaSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
June 16, 2026P160021/S052GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticePRLaccessdata.fda.gov
June 12, 2026P250031VENTANA PTEN (SP218) RxDx AssayVentana Medical Systems, Inc. (Roche Tissue Diagnostics)ArizonaApprovedPMA original approvalSHFaccessdata.fda.gov
June 10, 2026P180037/S015Venovo™ Venous Stent SystemBard Peripheral Vascular, Inc.Arizona30-day notice acceptedPMA 30-day noticeQANaccessdata.fda.gov
June 10, 2026P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc.Arizona30-day notice acceptedPMA 30-day noticePFVaccessdata.fda.gov
June 10, 2026P130029/S014Bard™ Fluency™ Plus Endovascular Stent GraftBard Peripheral Vascular, Inc.Arizona30-day notice acceptedPMA 30-day noticePFVaccessdata.fda.gov
June 10, 2026P070014/S069LifeStent™ 5F Vascular Stent SystemsBard Peripheral Vascular, Inc.Arizona30-day notice acceptedPMA 30-day noticeNIPaccessdata.fda.gov
May 28, 2026P240010/S009MI Cancer Seek®Caris Life SciencesArizona30-day notice acceptedPMA 30-day noticePQPaccessdata.fda.gov
May 26, 2026P130006/S111GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticePFVaccessdata.fda.gov
May 26, 2026P040037/S172GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeNIPaccessdata.fda.gov
May 15, 2026P990081/S058PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.ArizonaApprovedPMA 180-day supplementMVCaccessdata.fda.gov
May 15, 2026P190031/S015HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.ArizonaApprovedPMA 180-day supplementNYQaccessdata.fda.gov
May 15, 2026P070014/S068LifeStent 5F Vascular Stent SystemBard Peripheral Vascular, Inc.ArizonaApprovedPMA real-time process supplementNIPaccessdata.fda.gov
May 14, 2026P200030/S024GORE® EXCLUDER® Conformable AAA EndoprosthesisW. L. Gore and Associates, Inc.ArizonaApprovedPMA real-time process supplementMIHaccessdata.fda.gov
May 14, 2026P020004/S205GORE® EXCLUDER® AAA EndoprosthesisW. L. Gore & Associates, Inc.ArizonaApprovedPMA real-time process supplementMIHaccessdata.fda.gov
May 8, 2026P050006/S118GORE® CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMLVaccessdata.fda.gov
May 6, 2026K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba CorventionArizonaSubstantially Equivalent510(k) traditionalOZTaccessdata.fda.gov
April 30, 2026P250017/S003GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeQTLaccessdata.fda.gov
April 28, 2026P020004/S206GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
April 16, 2026K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.ArizonaSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
April 9, 2026P230023/S011GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE)W. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeQZKaccessdata.fda.gov
April 7, 2026P250017/S001GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.ArizonaApprovedPMA 180-day supplementQTLaccessdata.fda.gov
March 18, 2026K252961Fusion FibFix NailFusion Orthopedics USA, LLCArizonaSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov
March 10, 2026P070014/S067LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEMBard Peripheral Vascular, Inc.ArizonaApprovedPMA real-time process supplementNIPaccessdata.fda.gov
March 9, 2026P210032/S025GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SystemW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
March 9, 2026P040043/S149GORE® TAG® Conformable Thoracic EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
March 9, 2026P040043/S148GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SystemW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
March 6, 2026P250017/S002GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeQTLaccessdata.fda.gov
March 4, 2026K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.ArizonaSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov
February 20, 2026P050006/S117GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMLVaccessdata.fda.gov
February 20, 2026P030011/S097SynCardia Total Artificial Heart (STAH) SystemSyncardia Systems, LLCArizonaApprovedPMA real-time process supplementLOZaccessdata.fda.gov
February 11, 2026K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista MedicalArizonaSubstantially Equivalent510(k) traditionalQBPaccessdata.fda.gov
February 5, 2026P160021/S050GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticePRLaccessdata.fda.gov
February 4, 2026K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.ArizonaSubstantially Equivalent510(k) specialPNOaccessdata.fda.gov
January 15, 2026P230023/S010GORE® EXCLUDER® Thoracoabdominal Branch EndoprosthesisW. L. Gore & Associates, Inc.ArizonaApprovedPMA 180-day supplementQZKaccessdata.fda.gov
January 14, 2026K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.ArizonaSubstantially Equivalent510(k) traditionalOXOaccessdata.fda.gov
January 7, 2026K250305Reprocessed Agilis NxT Steerable IntroducerInnovative HealthArizonaSubstantially Equivalent510(k) traditionalPNEaccessdata.fda.gov
January 6, 2026P210001/S015VENTANA anti-MSH6 (SP93) AntibodyVentana Medical Systems, Inc. (Roche Tissue Diagnostics)Arizona30-day notice acceptedPMA 30-day noticeQNHaccessdata.fda.gov
January 6, 2026P200019/S013VENTANA anti-MSH6 (SP93) AntibodyVentana Medical SystemsArizona30-day notice acceptedPMA 30-day noticeQNHaccessdata.fda.gov
December 19, 2025P250017GORE® VIABAHN® FORTEGRA Venous StentW. L. Gore & Associates, Inc.ArizonaApprovedPMA original approvalQTLaccessdata.fda.gov
December 19, 2025P050006/S116GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMLVaccessdata.fda.gov
December 17, 2025P030011/S096SynCardia Total Artificial Heart (STAH) systemSyncardia Systems, LLCArizonaApprovedPMA real-time process supplementLOZaccessdata.fda.gov
December 16, 2025P170042/S014Covera™ Vascular Covered StentC.R. Bard, Inc.Arizona30-day notice acceptedPMA 30-day noticePFVaccessdata.fda.gov
December 16, 2025P070014/S066LifeStent® Vascular Stent SystemsBard Peripheral Vascular, Inc.Arizona30-day notice acceptedPMA 30-day noticeNIPaccessdata.fda.gov
December 15, 2025P990081/S059PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.ArizonaApprovedPMA 180-day supplementMVCaccessdata.fda.gov
December 15, 2025P190031/S014HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.ArizonaApprovedPMA 180-day supplementNYQaccessdata.fda.gov
December 12, 2025K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.ArizonaSubstantially Equivalent510(k) traditionalKNWaccessdata.fda.gov
December 5, 2025P200030/S023GORE® EXCLUDER® Conformable AAA EndoprosthesisW. L. Gore and Associates, Inc.ArizonaApprovedPMA real-time process supplementMIHaccessdata.fda.gov
November 24, 2025P160021/S048GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisW. L. Gore & Associates, Inc.ArizonaApprovedPMA 180-day supplementPRLaccessdata.fda.gov
November 19, 2025P030011/S093Total Artificial HeartSyncardia Systems, LLCArizonaApprovedPMA 180-day supplementLOZaccessdata.fda.gov
November 6, 2025K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.ArizonaSubstantially Equivalent510(k) traditionalNGXaccessdata.fda.gov
October 27, 2025P040027/S099GORE® VIATORR® TIPS Endoprosthesis with Controlled ExpansionW. L. Gore & Associates, Inc.ArizonaApprovedPMA 180-day supplementMIRaccessdata.fda.gov
October 27, 2025K251824Patriot DuoPatriot Laser, LLCArizonaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
October 17, 2025P210032/S024GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
October 17, 2025P160021/S049GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticePRLaccessdata.fda.gov
October 17, 2025P130006/S110GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticePFVaccessdata.fda.gov
October 17, 2025P040037/S171GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeNIPaccessdata.fda.gov
October 15, 2025P040043/S147GORE® TAG® Conformable Thoracic EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
October 9, 2025P020004/S204GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
October 2, 2025P040043/S146GORE® TAG® Conformable Thoracic EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
September 29, 2025P160024/S014LifeStream™ Balloon Expandable Vascular Covered StentBard Peripheral Vascular, Inc.Arizona30-day notice acceptedPMA 30-day noticePRLaccessdata.fda.gov
September 24, 2025K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.ArizonaSubstantially Equivalent510(k) traditionalMUHaccessdata.fda.gov
September 9, 2025P230023/S009GORE® EXCLUDER® Thoracoabdominal Branch EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeQZKaccessdata.fda.gov
September 9, 2025P210032/S023GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
September 9, 2025P040043/S145Conformable GORE® TAG® Thoracic EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
September 9, 2025P020004/S203GORE® EXCLUDER® Iliac Branch EndoprosthesisW. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
September 4, 2025P190024/S015CINtec PLUS CytologyVentana Medical Systems, Inc.Arizona30-day notice acceptedPMA 30-day noticeQKFaccessdata.fda.gov
August 29, 2025P200030/S022GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941...W. L. Gore and Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
August 29, 2025P040043/S144GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) 00733132646890; 00733132646906...W. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
August 27, 2025K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.ArizonaSubstantially Equivalent510(k) traditionalOCTaccessdata.fda.gov
August 25, 2025P210032/S022TAG® Thoracic Branch Endoprosthesis (P210032)W. L. Gore & Associates, Inc.Arizona30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
August 21, 2025P210032/S019GORE TAG Thoracic Branch Endoprosthesis (TBE Device)W. L. Gore & Associates, Inc.ArizonaApprovedPMA 180-day supplementMIHaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
W. L. Gore & Associates, Inc.73October 8, 2026
Ventana Medical Systems, Inc.24August 25, 2026
Bard Peripheral Vascular, Inc.21October 23, 2026
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)10October 23, 2026
W. L. Gore and Associates, Inc.9July 29, 2026
Caris Life Sciences8October 16, 2026
Syncardia Systems, LLC6July 9, 2026
Ventana Medical Systems5October 8, 2026
C.R. Bard, Inc.3June 10, 2026
Ziehm-Orthoscan, Inc.3January 14, 2026
Foundation Surgical Group2July 31, 2026
Stryker Sustainability Solutions2June 18, 2026
Mindset Medical, Inc.2May 30, 2025
Roche Tissue Diagnostics, Inc.1October 23, 2026
Innovative Health, LLC1October 19, 2026
Costa Surgical, Inc.1September 23, 2026
Sequitur Health Corp.1September 1, 2026
Nipro Technical Solutions, Incoporated1August 19, 2026
Accurate Access, LLC1July 27, 2026
Intervention Tech, Inc. ; dba Corvention1May 6, 2026

By panel

PanelDecisionsLatest
Cardiovascular112October 23, 2026
Pathology36October 23, 2026
Medical Genetics10October 16, 2026
Gastroenterology, Urology7August 19, 2026
Orthopedic6September 23, 2026
Radiology4July 27, 2026
General, Plastic Surgery4June 18, 2026
Neurology2April 16, 2026
Immunology1October 23, 2026
Clinical Chemistry1September 1, 2026
General Hospital1February 11, 2026
Physical Medicine1November 6, 2025
Dental1September 24, 2025
Unknown1August 14, 2025
Hematology1December 5, 2024

By decision type

Decision typeDecisionsLatest
PMA 30-day notice88October 23, 2026
PMA 180-day supplement32October 23, 2026
510(k) traditional31October 23, 2026
PMA real-time process supplement16October 16, 2026
510(k) special8August 14, 2026
PMA panel track supplement6October 8, 2026
PMA original approval4September 25, 2026
PMA special supplement2August 3, 2026
De Novo1December 5, 2024

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.