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 date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
|---|---|---|---|---|---|---|---|---|
| October 23, 2026 | P250050/S001 | Liverty TIPS Stent Graft | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIR | accessdata.fda.gov |
| October 23, 2026 | P240037/S003 | VENTANA MET (SP44) RxDx Assay | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Arizona | Approved | PMA 180-day supplement | SER | accessdata.fda.gov |
| October 23, 2026 | K260776 | VENTANA MMR IHC Panel | Roche Tissue Diagnostics, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | PZJ | accessdata.fda.gov |
| October 19, 2026 | K262917 | Reprocessed BRK Transseptal Needle | Innovative Health, LLC | Arizona | Substantially Equivalent | 510(k) traditional | NMK | accessdata.fda.gov |
| October 16, 2026 | P240010/S007 | MI Cancer Seek | Caris Life Sciences | Arizona | Approved | PMA real-time process supplement | PQP | accessdata.fda.gov |
| October 8, 2026 | P210001/S016 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Arizona | Approved | PMA 180-day supplement | QNH | accessdata.fda.gov |
| October 8, 2026 | P200019/S014 | VENTANA MMR RxDx Panel | Ventana Medical Systems | Arizona | Approved | PMA 180-day supplement | QNH | accessdata.fda.gov |
| October 8, 2026 | P160021/S051 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA panel track supplement | PRL | accessdata.fda.gov |
| September 25, 2026 | P250050 | Liverty TIPS Stent Graft | Bard Peripheral Vascular, Inc. | Arizona | Approved | PMA original approval | MIR | accessdata.fda.gov |
| September 23, 2026 | K261892 | ProRib Fixation System | Costa Surgical, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | HRS | accessdata.fda.gov |
| September 1, 2026 | K260613 | AMI Plasma Cartridge, AMI | Sequitur Health Corp. | Arizona | Substantially Equivalent | 510(k) traditional | JID | accessdata.fda.gov |
| August 25, 2026 | P990081/S060 | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | Arizona | Approved | PMA panel track supplement | MVC | accessdata.fda.gov |
| August 25, 2026 | P190031/S016 | VENTANA HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. | Arizona | Approved | PMA panel track supplement | NYQ | accessdata.fda.gov |
| August 19, 2026 | K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | Arizona | Substantially Equivalent | 510(k) traditional | KPO | accessdata.fda.gov |
| August 14, 2026 | K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Arizona | Substantially Equivalent | 510(k) special | KNW | accessdata.fda.gov |
| August 3, 2026 | P050006/S119 | GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA special supplement | MLV | accessdata.fda.gov |
| July 31, 2026 | K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | Arizona | Substantially Equivalent | 510(k) special | MQP | accessdata.fda.gov |
| July 31, 2026 | K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | Arizona | Substantially Equivalent | 510(k) special | OVD | accessdata.fda.gov |
| July 29, 2026 | P200030/S026 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| July 27, 2026 | K262474 | ND Needle Guidance System | Accurate Access, LLC | Arizona | Substantially Equivalent | 510(k) traditional | ITX | accessdata.fda.gov |
| July 13, 2026 | P210032/S026 | GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA 180-day supplement | MIH | accessdata.fda.gov |
| July 9, 2026 | P030011/S099 | SynCardia Temporary Total Artificial Heart (TAH-t) System Freedom Driver System | Syncardia Systems, LLC | Arizona | 30-day notice accepted | PMA 30-day notice | LOZ | accessdata.fda.gov |
| July 8, 2026 | P200030/S025 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | Arizona | Approved | PMA real-time process supplement | MIH | accessdata.fda.gov |
| July 8, 2026 | P020004/S207 | GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA real-time process supplement | MIH | accessdata.fda.gov |
| July 2, 2026 | P240010/S010 | MI Cancer Seek | Caris Life Sciences | Arizona | 30-day notice accepted | PMA 30-day notice | PQP | accessdata.fda.gov |
| July 1, 2026 | P230023/S012 | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA special supplement | QZK | accessdata.fda.gov |
| June 23, 2026 | P020004/S208 | GORE® EXCLUDER® AAA Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| June 22, 2026 | P130029/S015 | Fluency Plus Endovascular Stent Graft | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PFV | accessdata.fda.gov |
| June 18, 2026 | K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | Arizona | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| June 16, 2026 | P160021/S052 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PRL | accessdata.fda.gov |
| June 12, 2026 | P250031 | VENTANA PTEN (SP218) RxDx Assay | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Arizona | Approved | PMA original approval | SHF | accessdata.fda.gov |
| June 10, 2026 | P180037/S015 | Venovo Venous Stent System | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | QAN | accessdata.fda.gov |
| June 10, 2026 | P170042/S015 | Covera Vascular Covered Stent | C.R. Bard, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PFV | accessdata.fda.gov |
| June 10, 2026 | P130029/S014 | Bard Fluency Plus Endovascular Stent Graft | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PFV | accessdata.fda.gov |
| June 10, 2026 | P070014/S069 | LifeStent 5F Vascular Stent Systems | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | NIP | accessdata.fda.gov |
| May 28, 2026 | P240010/S009 | MI Cancer Seek® | Caris Life Sciences | Arizona | 30-day notice accepted | PMA 30-day notice | PQP | accessdata.fda.gov |
| May 26, 2026 | P130006/S111 | GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PFV | accessdata.fda.gov |
| May 26, 2026 | P040037/S172 | GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | NIP | accessdata.fda.gov |
| May 15, 2026 | P990081/S058 | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | Arizona | Approved | PMA 180-day supplement | MVC | accessdata.fda.gov |
| May 15, 2026 | P190031/S015 | HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. | Arizona | Approved | PMA 180-day supplement | NYQ | accessdata.fda.gov |
| May 15, 2026 | P070014/S068 | LifeStent 5F Vascular Stent System | Bard Peripheral Vascular, Inc. | Arizona | Approved | PMA real-time process supplement | NIP | accessdata.fda.gov |
| May 14, 2026 | P200030/S024 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | Arizona | Approved | PMA real-time process supplement | MIH | accessdata.fda.gov |
| May 14, 2026 | P020004/S205 | GORE® EXCLUDER® AAA Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA real-time process supplement | MIH | accessdata.fda.gov |
| May 8, 2026 | P050006/S118 | GORE® CARDIOFORM Septal Occluder | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MLV | accessdata.fda.gov |
| May 6, 2026 | K253855 | KardiaPSI Balloon Catheter | Intervention Tech, Inc. ; dba Corvention | Arizona | Substantially Equivalent | 510(k) traditional | OZT | accessdata.fda.gov |
| April 30, 2026 | P250017/S003 | GORE® VIABAHN® FORTEGRA Venous Stent | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | QTL | accessdata.fda.gov |
| April 28, 2026 | P020004/S206 | GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| April 16, 2026 | K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | OLO | accessdata.fda.gov |
| April 9, 2026 | P230023/S011 | GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | QZK | accessdata.fda.gov |
| April 7, 2026 | P250017/S001 | GORE® VIABAHN® FORTEGRA Venous Stent | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA 180-day supplement | QTL | accessdata.fda.gov |
| March 18, 2026 | K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | Arizona | Substantially Equivalent | 510(k) traditional | HSB | accessdata.fda.gov |
| March 10, 2026 | P070014/S067 | LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM | Bard Peripheral Vascular, Inc. | Arizona | Approved | PMA real-time process supplement | NIP | accessdata.fda.gov |
| March 9, 2026 | P210032/S025 | GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| March 9, 2026 | P040043/S149 | GORE® TAG® Conformable Thoracic Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| March 9, 2026 | P040043/S148 | GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| March 6, 2026 | P250017/S002 | GORE® VIABAHN® FORTEGRA Venous Stent | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | QTL | accessdata.fda.gov |
| March 4, 2026 | K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | HSB | accessdata.fda.gov |
| February 20, 2026 | P050006/S117 | GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal Occluder | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MLV | accessdata.fda.gov |
| February 20, 2026 | P030011/S097 | SynCardia Total Artificial Heart (STAH) System | Syncardia Systems, LLC | Arizona | Approved | PMA real-time process supplement | LOZ | accessdata.fda.gov |
| February 11, 2026 | K251592 | SteriHub Disinfecting Device and Protective Cover | 1World Vista Medical | Arizona | Substantially Equivalent | 510(k) traditional | QBP | accessdata.fda.gov |
| February 5, 2026 | P160021/S050 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PRL | accessdata.fda.gov |
| February 4, 2026 | K260012 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | Arizona | Substantially Equivalent | 510(k) special | PNO | accessdata.fda.gov |
| January 15, 2026 | P230023/S010 | GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA 180-day supplement | QZK | accessdata.fda.gov |
| January 14, 2026 | K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | OXO | accessdata.fda.gov |
| January 7, 2026 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | Arizona | Substantially Equivalent | 510(k) traditional | PNE | accessdata.fda.gov |
| January 6, 2026 | P210001/S015 | VENTANA anti-MSH6 (SP93) Antibody | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Arizona | 30-day notice accepted | PMA 30-day notice | QNH | accessdata.fda.gov |
| January 6, 2026 | P200019/S013 | VENTANA anti-MSH6 (SP93) Antibody | Ventana Medical Systems | Arizona | 30-day notice accepted | PMA 30-day notice | QNH | accessdata.fda.gov |
| December 19, 2025 | P250017 | GORE® VIABAHN® FORTEGRA Venous Stent | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA original approval | QTL | accessdata.fda.gov |
| December 19, 2025 | P050006/S116 | GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MLV | accessdata.fda.gov |
| December 17, 2025 | P030011/S096 | SynCardia Total Artificial Heart (STAH) system | Syncardia Systems, LLC | Arizona | Approved | PMA real-time process supplement | LOZ | accessdata.fda.gov |
| December 16, 2025 | P170042/S014 | Covera Vascular Covered Stent | C.R. Bard, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PFV | accessdata.fda.gov |
| December 16, 2025 | P070014/S066 | LifeStent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | NIP | accessdata.fda.gov |
| December 15, 2025 | P990081/S059 | PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | Arizona | Approved | PMA 180-day supplement | MVC | accessdata.fda.gov |
| December 15, 2025 | P190031/S014 | HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. | Arizona | Approved | PMA 180-day supplement | NYQ | accessdata.fda.gov |
| December 12, 2025 | K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | KNW | accessdata.fda.gov |
| December 5, 2025 | P200030/S023 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | Arizona | Approved | PMA real-time process supplement | MIH | accessdata.fda.gov |
| November 24, 2025 | P160021/S048 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA 180-day supplement | PRL | accessdata.fda.gov |
| November 19, 2025 | P030011/S093 | Total Artificial Heart | Syncardia Systems, LLC | Arizona | Approved | PMA 180-day supplement | LOZ | accessdata.fda.gov |
| November 6, 2025 | K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | NGX | accessdata.fda.gov |
| October 27, 2025 | P040027/S099 | GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA 180-day supplement | MIR | accessdata.fda.gov |
| October 27, 2025 | K251824 | Patriot Duo | Patriot Laser, LLC | Arizona | Substantially Equivalent | 510(k) traditional | GEX | accessdata.fda.gov |
| October 17, 2025 | P210032/S024 | GORE® TAG® Thoracic Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| October 17, 2025 | P160021/S049 | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PRL | accessdata.fda.gov |
| October 17, 2025 | P130006/S110 | GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PFV | accessdata.fda.gov |
| October 17, 2025 | P040037/S171 | GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | NIP | accessdata.fda.gov |
| October 15, 2025 | P040043/S147 | GORE® TAG® Conformable Thoracic Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| October 9, 2025 | P020004/S204 | GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| October 2, 2025 | P040043/S146 | GORE® TAG® Conformable Thoracic Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| September 29, 2025 | P160024/S014 | LifeStream Balloon Expandable Vascular Covered Stent | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | PRL | accessdata.fda.gov |
| September 24, 2025 | K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | MUH | accessdata.fda.gov |
| September 9, 2025 | P230023/S009 | GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | QZK | accessdata.fda.gov |
| September 9, 2025 | P210032/S023 | GORE® TAG® Thoracic Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| September 9, 2025 | P040043/S145 | Conformable GORE® TAG® Thoracic Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| September 9, 2025 | P020004/S203 | GORE® EXCLUDER® Iliac Branch Endoprosthesis | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| September 4, 2025 | P190024/S015 | CINtec PLUS Cytology | Ventana Medical Systems, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | QKF | accessdata.fda.gov |
| August 29, 2025 | P200030/S022 | GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941... | W. L. Gore and Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| August 29, 2025 | P040043/S144 | GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) 00733132646890; 00733132646906... | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| August 27, 2025 | K251068 | KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | OCT | accessdata.fda.gov |
| August 25, 2025 | P210032/S022 | TAG® Thoracic Branch Endoprosthesis (P210032) | W. L. Gore & Associates, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIH | accessdata.fda.gov |
| August 21, 2025 | P210032/S019 | GORE TAG Thoracic Branch Endoprosthesis (TBE Device) | W. L. Gore & Associates, Inc. | Arizona | Approved | PMA 180-day supplement | MIH | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 73 | October 8, 2026 |
| Ventana Medical Systems, Inc. | 24 | August 25, 2026 |
| Bard Peripheral Vascular, Inc. | 21 | October 23, 2026 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 10 | October 23, 2026 |
| W. L. Gore and Associates, Inc. | 9 | July 29, 2026 |
| Caris Life Sciences | 8 | October 16, 2026 |
| Syncardia Systems, LLC | 6 | July 9, 2026 |
| Ventana Medical Systems | 5 | October 8, 2026 |
| C.R. Bard, Inc. | 3 | June 10, 2026 |
| Ziehm-Orthoscan, Inc. | 3 | January 14, 2026 |
| Foundation Surgical Group | 2 | July 31, 2026 |
| Stryker Sustainability Solutions | 2 | June 18, 2026 |
| Mindset Medical, Inc. | 2 | May 30, 2025 |
| Roche Tissue Diagnostics, Inc. | 1 | October 23, 2026 |
| Innovative Health, LLC | 1 | October 19, 2026 |
| Costa Surgical, Inc. | 1 | September 23, 2026 |
| Sequitur Health Corp. | 1 | September 1, 2026 |
| Nipro Technical Solutions, Incoporated | 1 | August 19, 2026 |
| Accurate Access, LLC | 1 | July 27, 2026 |
| Intervention Tech, Inc. ; dba Corvention | 1 | May 6, 2026 |
By panel
| Panel | Decisions | Latest |
|---|---|---|
| Cardiovascular | 112 | October 23, 2026 |
| Pathology | 36 | October 23, 2026 |
| Medical Genetics | 10 | October 16, 2026 |
| Gastroenterology, Urology | 7 | August 19, 2026 |
| Orthopedic | 6 | September 23, 2026 |
| Radiology | 4 | July 27, 2026 |
| General, Plastic Surgery | 4 | June 18, 2026 |
| Neurology | 2 | April 16, 2026 |
| Immunology | 1 | October 23, 2026 |
| Clinical Chemistry | 1 | September 1, 2026 |
| General Hospital | 1 | February 11, 2026 |
| Physical Medicine | 1 | November 6, 2025 |
| Dental | 1 | September 24, 2025 |
| Unknown | 1 | August 14, 2025 |
| Hematology | 1 | December 5, 2024 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| PMA 30-day notice | 88 | October 23, 2026 |
| PMA 180-day supplement | 32 | October 23, 2026 |
| 510(k) traditional | 31 | October 23, 2026 |
| PMA real-time process supplement | 16 | October 16, 2026 |
| 510(k) special | 8 | August 14, 2026 |
| PMA panel track supplement | 6 | October 8, 2026 |
| PMA original approval | 4 | September 25, 2026 |
| PMA special supplement | 2 | August 3, 2026 |
| De Novo | 1 | December 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.