# FDA device clearances in Florida: 301 since Nov 2024

Updated October 30, 2026.

FDA made 301 device decisions for applicants in Florida from November 13, 2024 to October 30, 2026: 205 510(k) clearances and De Novo grants and 96 PMA approvals and supplements, for 105 applicants. The newest, K263075 on October 30, 2026, is Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments from Strauss Surgical USA.

## The full list

FDA device clearances for applicants in Florida: 301 rows for $15.05, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 11 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/state/florida

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.

- Decisions: 301
- 510(k) and De Novo: 205
- PMA: 96
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 301, 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 30, 2026 | K263075 | Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments | Strauss Surgical USA | Florida | Substantially Equivalent | 510(k) traditional | FAJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263075) |
| October 29, 2026 | K263602 | Arthrex Plates, Screws and Pins, and Washers | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263602) |
| October 28, 2026 | P200045/S025 | RelayPro Thoracic Stent-Graft Delivery System | Bolton Medical, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200045S025) |
| October 27, 2026 | K263477 | Arthrex FiberButton | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263477) |
| October 26, 2026 | K261135 | Trochlear Salvage Plating System | Skeletal Dynamics, Inc. | Florida | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261135) |
| October 23, 2026 | P990040/S037 | TRUFILL n-BCA Liquid Embolic System | Cerenovus, Inc. | Florida | Approved | PMA 180-day supplement | KGG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990040S037) |
| October 23, 2026 | P200020/S013 | ClearView™ HD intraocular lens (IOL) | Lenstec, Inc. | Florida | Approved | PMA 180-day supplement | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200020S013) |
| October 21, 2026 | K252736 | Hemotag Analysis Software (HAS) | Aventusoft, LLC | Florida | Substantially Equivalent | 510(k) traditional | DQD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252736) |
| October 16, 2026 | P040045/S147 | VISTAKON® (senofilcon A) Brand Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S147) |
| October 15, 2026 | P120002/S036 | S.M.A.R.T. and S.M.A.R.T. ® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System | Cordis US Corporation | Florida | 30-day notice accepted | PMA 30-day notice | NIP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120002S036) |
| October 15, 2026 | P020036/S061 | S.M.A.R.T. ® CONTROL® Nitinol Stent System | Cordis US Corporation | Florida | 30-day notice accepted | PMA 30-day notice | NIO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020036S061) |
| October 15, 2026 | K260530 | epi-ConneKt™ Wound Matrix | MLM Biologics, Inc. | Florida | Substantially Equivalent | 510(k) traditional | KGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260530) |
| October 14, 2026 | K263208 | Vantage Lumbar Decompression Kit | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) special | HRX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263208) |
| October 13, 2026 | K261321 | Yomi S Robotic System | Neocis, Inc. | Florida | Substantially Equivalent | 510(k) traditional | QRY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261321) |
| October 9, 2026 | K261521 | Sleep Analysis Module | Neurotronics, LLC | Florida | Substantially Equivalent | 510(k) traditional | OLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261521) |
| October 8, 2026 | P040045/S146 | VISTAKON (SENOFILCON A) Brand Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S146) |
| October 7, 2026 | K262134 | NeuroDR | Deep Reasoning Ai, Inc. | Florida | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262134) |
| October 2, 2026 | K263083 | Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | Florida | Substantially Equivalent | 510(k) special | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263083) |
| September 25, 2026 | K262975 | Arthrex Beaming System | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262975) |
| September 24, 2026 | K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | MRW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262618) |
| September 22, 2026 | K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | Florida | Substantially Equivalent | 510(k) traditional | PBX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243223) |
| September 21, 2026 | K260940 | BellaTek Bars | ZimVie US Corp, LLC | Florida | Substantially Equivalent | 510(k) special | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260940) |
| September 17, 2026 | K252995 | Durashield Device Kit | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) traditional | GZT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252995) |
| September 15, 2026 | K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | Florida | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262963) |
| September 14, 2026 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System... | Xenix Medical | Florida | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262193) |
| September 4, 2026 | K262235 | ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking... | Medtronic Xomed, Inc. | Florida | Substantially Equivalent | 510(k) traditional | PGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262235) |
| September 4, 2026 | K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | Florida | Substantially Equivalent | 510(k) traditional | EZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260756) |
| September 2, 2026 | P040045/S145 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S145) |
| September 2, 2026 | K260432 | Ruby Intravascular Catheter | Venocare, Inc. | Florida | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260432) |
| September 1, 2026 | K262451 | Arthrex DynaNite Staples | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | JDR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262451) |
| August 26, 2026 | K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) special | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262581) |
| August 24, 2026 | K261381 | TiLink-L™ SI Joint Fusion System | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) traditional | OUR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261381) |
| August 21, 2026 | K261710 | AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors | Apyx Medical Corporation | Florida | Substantially Equivalent | 510(k) traditional | QPB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261710) |
| August 21, 2026 | DEN250026 | Avulux | Matap Ii, LLC | Florida | Unknown | De Novo | QEO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250026) |
| August 18, 2026 | K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. | Florida | Substantially Equivalent | 510(k) traditional | HIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260984) |
| August 17, 2026 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual... | KLS-Martin L.P. | Florida | Substantially Equivalent | 510(k) traditional | JEY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260137) |
| August 14, 2026 | K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | Florida | Substantially Equivalent | 510(k) traditional | MWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260438) |
| August 13, 2026 | K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | Florida | Substantially Equivalent | 510(k) special | NRY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262398) |
| August 13, 2026 | K261061 | BP Go (BPP-855) | Wellvii, Inc. | Florida | Substantially Equivalent | 510(k) traditional | DXN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261061) |
| August 7, 2026 | K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | MAI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262357) |
| August 7, 2026 | K261905 | BUM Oil | Bumlicious, LLC (DBA “Bumlicious”) | Florida | Substantially Equivalent | 510(k) traditional | NUC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261905) |
| July 30, 2026 | K260624 | Arthrex Radial Head Replacement System | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | KWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260624) |
| July 30, 2026 | K252042 | Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. | Florida | Substantially Equivalent | 510(k) traditional | LDF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252042) |
| July 29, 2026 | K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | Florida | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261770) |
| July 28, 2026 | K261399 | ELISIO™-HX | Nipro Medical Corporation | Florida | Substantially Equivalent | 510(k) traditional | QAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261399) |
| July 27, 2026 | P020016/S010 | Total Temporomandibular Joint Replacement System | Biomet Microfixation, Inc. | Florida | Approved | PMA 180-day supplement |  | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020016S010) |
| July 24, 2026 | K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) special | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262121) |
| July 24, 2026 | K261312 | Temporary Keratoprosthesis (QuickSet TKP™) | Eyekon Medical, Inc. | Florida | Substantially Equivalent | 510(k) traditional | MLP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261312) |
| July 23, 2026 | K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | Florida | Substantially Equivalent | 510(k) special | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262116) |
| July 15, 2026 | K252822 | Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | Florida | Substantially Equivalent | 510(k) traditional | PLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252822) |
| July 10, 2026 | K262120 | Avara Viewer | Avara Software | Florida | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262120) |
| June 26, 2026 | K260018 | Arthrex FiberButton | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260018) |
| June 26, 2026 | K253306 | BioTracker 2.0 | Biotracker, LLC | Florida | Substantially Equivalent | 510(k) traditional |  | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253306) |
| June 25, 2026 | K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260809) |
| June 23, 2026 | P100013/S034 | Exoseal Vascular Closure Device | Cordis US Corporation | Florida | Approved | PMA special supplement | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100013S034) |
| June 18, 2026 | P200045/S024 | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200045S024) |
| June 18, 2026 | P190015/S030 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190015S030) |
| June 17, 2026 | K260916 | FLEXI-PORT™ Power Injectable Implantable Port | Portal Access, Inc. | Florida | Substantially Equivalent | 510(k) traditional | LJT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260916) |
| June 15, 2026 | K260126 | Curajel™ Oral Gel | USpharma, Ltd. | Florida | Substantially Equivalent | 510(k) traditional | OLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260126) |
| June 11, 2026 | K261209 | Ion-L | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) traditional | MRW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261209) |
| June 8, 2026 | K251944 | Lipocosm Harmonic System | Lipocosm, LLC | Florida | Substantially Equivalent | 510(k) traditional | QPB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251944) |
| June 5, 2026 | P030047/S055 | PRECISE PRO RX Nitinol Stent System | Cordis US Corporation | Florida | Approved | PMA special supplement | NIM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030047S055) |
| June 5, 2026 | K253204 | Catalyze | BioTissue Holdings, Inc. | Florida | Substantially Equivalent | 510(k) traditional | KGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253204) |
| June 4, 2026 | K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | Florida | Substantially Equivalent | 510(k) traditional | HIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253020) |
| June 3, 2026 | K261484 | Tissue Approximation System | Tas Medical, Inc. | Florida | Substantially Equivalent | 510(k) special | GAR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261484) |
| June 2, 2026 | K261002 | Pectus Blu System | Biomet Microfixation | Florida | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261002) |
| June 2, 2026 | K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | Florida | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253918) |
| May 28, 2026 | K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | MAI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253931) |
| May 28, 2026 | K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | Florida | Substantially Equivalent | 510(k) traditional | GZJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252712) |
| May 26, 2026 | P990040/S038 | TRUFILL n-BCA Liquid Embolic System | Cerenovus, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | KGG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990040S038) |
| May 22, 2026 | K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260329) |
| May 14, 2026 | P040044/S113 | Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Venous Vascular Closure | Cordis US Corporation | Florida | Approved | PMA special supplement | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040044S113) |
| May 12, 2026 | K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | Florida | Substantially Equivalent | 510(k) traditional | ODP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260850) |
| May 8, 2026 | K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | Florida | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260321) |
| May 8, 2026 | K254215 | Arthrex Beaming System | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254215) |
| May 8, 2026 | K253396 | AYON Body Contouring System™ (AYON SYSTEM) | Apyx Medical Corporation | Florida | Substantially Equivalent | 510(k) traditional | QPB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253396) |
| May 4, 2026 | P040045/S144 | VISTAKON® (senofilcon A) contact lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S144) |
| April 29, 2026 | P040045/S143 | VISTAKON® (senofilcon A) Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S143) |
| April 29, 2026 | K252471 | Paptizer 360 | LiViliti Health Products Corporation | Florida | Substantially Equivalent | 510(k) traditional | QXQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252471) |
| April 23, 2026 | K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | Florida | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252407) |
| April 17, 2026 | P040045/S142 | VISTAKON® (senofilcon A) Brand Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S142) |
| April 17, 2026 | N18033/S114 | VISTAKON® (etafilcon A) Brand Contact Lenses | Vistakon, Johnson & Johnson Vision Products, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N18033S114) |
| April 16, 2026 | K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°... | Strauss Surgical USA | Florida | Substantially Equivalent | 510(k) traditional | FAJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253892) |
| April 15, 2026 | P200020/S012 | Clearview 3 | Lenstec, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200020S012) |
| April 15, 2026 | P090022/S049 | Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM | Lenstec, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090022S049) |
| April 14, 2026 | K260583 | Equinoxe® Shoulder System | Exactech, Inc. | Florida | Substantially Equivalent | 510(k) traditional | PHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260583) |
| April 13, 2026 | P200045/S017 | RelayPro Thoracic Stent-Graft System | Bolton Medical, Inc. | Florida | Approved | PMA 180-day supplement | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200045S017) |
| April 13, 2026 | P190015/S024 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | Florida | Approved | PMA 180-day supplement | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190015S024) |
| April 13, 2026 | K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT... | HC Biologics, LLC | Florida | Substantially Equivalent | 510(k) traditional | ODP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260340) |
| April 7, 2026 | K254191 | IWD-Gel™ | InnovaCorium, Inc. | Florida | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254191) |
| April 3, 2026 | DEN240071 | neuropacs | Automated Imaging Diagnostics, LLC | Florida | Unknown | De Novo | SHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240071) |
| March 31, 2026 | P040044/S111 | Mynx Control Vascular Closure Device (5F, 6F/7F) | Cordis US Corporation | Florida | 30-day notice accepted | PMA 30-day notice | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040044S111) |
| March 27, 2026 | K260271 | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy, Inc. | Florida | Substantially Equivalent | 510(k) traditional | FAJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260271) |
| March 26, 2026 | P190015/S026 | TREO® Abdominal Stent-Graft System | Bolton Medical, Inc. | Florida | Approved | PMA 180-day supplement | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190015S026) |
| March 25, 2026 | P200020/S011 | ClearView 3 IOL | Lenstec, Inc. | Florida | Approved | PMA real-time process supplement | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200020S011) |
| March 24, 2026 | K253047 | PRESSONE™ | Nipro Medical Corporation | Florida | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253047) |
| March 23, 2026 | K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | Florida | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254288) |
| March 20, 2026 | K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260561) |
| March 20, 2026 | K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253604) |
| March 20, 2026 | K252016 | Arthrex Humeral Nails | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) traditional | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252016) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Arthrex, Inc. | 41 | October 29, 2026 |
| Cordis US Corporation | 38 | October 15, 2026 |
| Bolton Medical, Inc. | 21 | October 28, 2026 |
| SurGenTec, LLC | 17 | October 14, 2026 |
| Vistakon, Division of Johnson & Johnson Vision Car | 9 | October 16, 2026 |
| Lenstec, Inc. | 8 | October 23, 2026 |
| Cerenovus, Inc. | 6 | October 23, 2026 |
| Skeletal Dynamics, Inc. | 5 | October 26, 2026 |
| KLS-Martin L.P. | 5 | August 17, 2026 |
| Exactech, Inc. | 5 | April 14, 2026 |
| Axora Medical, Inc. | 4 | August 18, 2026 |
| Atlas Spine, Inc. | 4 | July 15, 2026 |
| Rebotix | 4 | August 20, 2025 |
| Neocis, Inc. | 3 | October 13, 2026 |
| Venocare, Inc. | 3 | September 2, 2026 |
| Apyx Medical Corporation | 3 | August 21, 2026 |
| Nipro Medical Corporation | 3 | July 28, 2026 |
| American Medical Endoscopy, Inc. | 3 | June 4, 2026 |
| Vistakon, Johnson & Johnson Vision Products, Inc. | 3 | April 17, 2026 |
| InspireMD, Ltd. | 3 | March 16, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 92 | October 29, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 70 | October 28, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 22 | October 23, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 21 | October 23, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 20 | September 22, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 16 | October 30, 2026 |
| Unknown | 12 | October 15, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 11 | October 7, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 9 | October 13, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 9 | September 2, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 7 | August 18, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 3 | February 5, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 3 | July 18, 2025 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 2 | July 23, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 1 | April 23, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 1 | February 10, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 1 | September 10, 2025 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 1 | July 25, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 161 | October 30, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 65 | October 28, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 41 | October 29, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 13 | October 23, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 9 | June 23, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 6 | March 25, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 2 | August 21, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 2 | December 16, 2025 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | March 23, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 1 | June 23, 2025 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). 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](https://creativecommons.org/licenses/by/4.0/).