# FDA device clearances in Massachusetts: 485 since Nov 2024

Updated October 28, 2026.

FDA made 485 device decisions for applicants in Massachusetts from November 11, 2024 to October 28, 2026: 230 510(k) clearances and De Novo grants and 255 PMA approvals and supplements, for 139 applicants. The newest, P250051/S001 on October 28, 2026, is Juveena Hydrogel System from Rejoni, Inc..

## The full list

FDA device clearances for applicants in Massachusetts: 485 rows for $24.25, 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 24 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/massachusetts

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: 485
- 510(k) and De Novo: 230
- PMA: 255
- Latest decision: October 28, 2026

## Newest decisions

The newest 100 of 485, 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 28, 2026 | P250051/S001 | Juveena Hydrogel System | Rejoni, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | MCN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250051S001) |
| October 28, 2026 | P160013/S023 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | QBA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160013S023) |
| October 28, 2026 | K261630 | GI Windows Flexagon Plus OTOLoc System | GI Windows Surgical | Massachusetts | Substantially Equivalent | 510(k) traditional | SAH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261630) |
| October 27, 2026 | P240038/S004 | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240038S004) |
| October 27, 2026 | K263461 | Tendon Anchor | Smith & Nephew, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | GDW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263461) |
| October 26, 2026 | P170011/S064 | Impella RP Flex with SmartAssist | Abiomed, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | PYX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170011S064) |
| October 23, 2026 | P250003/S011 | Embrace® Hydrogel Embolic System | Instylla, Inc. | Massachusetts | Approved | PMA special supplement | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S011) |
| October 23, 2026 | P250003/S008 | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | Massachusetts | Approved | PMA panel track supplement | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S008) |
| October 23, 2026 | K263348 | Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor... | Smith & Nephew, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263348) |
| October 21, 2026 | P250003/S010 | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | Massachusetts | Approved | PMA special supplement | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S010) |
| October 19, 2026 | K261203 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | KDI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261203) |
| October 16, 2026 | P160022/S056 | ZOLL R Series Monitor/Defibrillator | ZOLL Medical Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160022S056) |
| October 16, 2026 | P160015/S029 | AED 3 Defibrillator with Uni-Padz | ZOLL Medical Corporation | Massachusetts | Approved | PMA 180-day supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160015S029) |
| October 16, 2026 | K260801 | Sensinel Cardiopulmonary Management (CPM) System | Analog Devices | Massachusetts | Substantially Equivalent | 510(k) traditional | MWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260801) |
| October 15, 2026 | N16837/S040 | Artegraft Collagen Vascular Graft | LeMaitre Vascular, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LXA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N16837S040) |
| October 13, 2026 | P200029/S015 | TheraSphere™ Y-90 Glass Microspheres System | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | NAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200029S015) |
| October 6, 2026 | K261887 | Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite... | NormaTec Industries, LP | Massachusetts | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261887) |
| October 2, 2026 | P160022/S054 | X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode... | ZOLL Medical Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160022S054) |
| October 2, 2026 | K263113 | ZSAlign Cervical Interbody System | ZSFab, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263113) |
| October 1, 2026 | P220014/S013 | CraniSeal™ Dural Sealant | Pramand, LLC | Massachusetts | Approved | PMA 180-day supplement | NQR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220014S013) |
| September 30, 2026 | K262893 | Eonis™ SMA kit | Revvity, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | QUE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262893) |
| September 29, 2026 | P800002/S036 | Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web Webber | C.R. Bard, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P800002S036) |
| September 29, 2026 | K262015 | Elucid FFR-IQ (B.1) | Elucid Bioimaging, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | PJA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262015) |
| September 28, 2026 | P250051 | Juveena Hydrogel System | Rejoni, Inc. | Massachusetts | Approved | PMA original approval | MCN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250051) |
| September 25, 2026 | P240038/S003 | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Massachusetts | Approved | PMA real-time process supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240038S003) |
| September 23, 2026 | P250023/S002 | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. | Massachusetts | Approved | PMA 180-day supplement | LTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250023S002) |
| September 23, 2026 | K262353 | BTL-299-F | BTL Industries, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | KPI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262353) |
| September 22, 2026 | K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | Massachusetts | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261125) |
| September 21, 2026 | K261725 | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | SHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261725) |
| September 18, 2026 | P190032/S032 | FoundationOne Liquid CDx (F1LCDx) | Foundation Medicine, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190032S032) |
| September 18, 2026 | K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261855) |
| September 17, 2026 | K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261869) |
| September 16, 2026 | P170019/S069 | FoundationOne CDx | Foundation Medicine, Inc. | Massachusetts | Approved | PMA 180-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170019S069) |
| September 16, 2026 | K262877 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser... | Olympus Surgical Technologies America | Massachusetts | Substantially Equivalent | 510(k) special | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262877) |
| September 16, 2026 | K260906 | a2z-Abdo-Triage | A2z Radiology Ai, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260906) |
| September 14, 2026 | P000053/S142 | AMS 800™ Artificial Urinary Sphincter (AUS) | Boston Scientific Corp | Massachusetts | 30-day notice accepted | PMA 30-day notice | EZY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000053S142) |
| September 14, 2026 | N970012/S212 | AMS 700™ Inflatable Penile Prosthesis (IPP) | Boston Scientific Corp | Massachusetts | 30-day notice accepted | PMA 30-day notice | JCW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N970012S212) |
| September 11, 2026 | P240027/S007 | SpineSeal™ Spine Sealant | Pramand, LLC | Massachusetts | Approved | PMA real-time process supplement | NQR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240027S007) |
| September 11, 2026 | K262151 | SpaceOAR Flex™ System | Boston Scientific Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | OVB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262151) |
| September 11, 2026 | K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | Massachusetts | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260063) |
| September 9, 2026 | P250023/S001 | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. | Massachusetts | Approved | PMA special supplement | LTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250023S001) |
| September 9, 2026 | P200036/S012 | eCoin Peripheral Neurostimulator | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | QPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200036S012) |
| September 4, 2026 | N16837/S039 | Artegraft Collagen Vascular Graft | LeMaitre Vascular, Inc. | Massachusetts | Approved | PMA special supplement | LXA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N16837S039) |
| September 3, 2026 | P250003/S009 | Embrace Hydrogel Embolic System | Instylla, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S009) |
| September 3, 2026 | K262460 | Rezum System | Boston Scientific | Massachusetts | Substantially Equivalent | 510(k) traditional | KNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262460) |
| September 2, 2026 | K261311 | HYALOMATRIX | Anika Therapeutics, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | QSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261311) |
| August 31, 2026 | P240027/S006 | SpineSeal Spine Sealant | Pramand, LLC | Massachusetts | Approved | PMA real-time process supplement | NQR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240027S006) |
| August 31, 2026 | K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | FPB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261403) |
| August 28, 2026 | P030019/S028 | Orthovisc Injectable Intra-Articular Devices | Anika Therapeutics, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | MOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030019S028) |
| August 28, 2026 | P000046/S032 | Ophthalmic Viscosurgical Device Family | Anika Therapeutics, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000046S032) |
| August 27, 2026 | P110024/S007 | ResQCPR System | ZOLL Medical Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | PIZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110024S007) |
| August 26, 2026 | K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | FGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261153) |
| August 25, 2026 | K261747 | Report Studio | Beacon Biosignals, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | OLV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261747) |
| August 25, 2026 | K254304 | iNOS intraoral biosensor | Achaemenid, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | PLC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254304) |
| August 23, 2026 | K260691 | BTL-699 | BTL Industries, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260691) |
| August 21, 2026 | P200029/S014 | TheraSphere | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | NAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200029S014) |
| August 21, 2026 | DEN250067 | ReneuRx™ (Neural Ice) | Brixton Biosciences | Massachusetts | Unknown | De Novo | SJA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250067) |
| August 20, 2026 | K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | MHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260579) |
| August 19, 2026 | K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | OLT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254213) |
| August 16, 2026 | K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | Massachusetts | Substantially Equivalent | 510(k) traditional | OLX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260563) |
| August 13, 2026 | K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261139) |
| August 13, 2026 | K260907 | BIS™ Advance pEEG Module | Covidien LP | Massachusetts | Substantially Equivalent | 510(k) traditional | OLW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260907) |
| August 12, 2026 | P190032/S030 | FoundationOne Liquid CDx (F1 Liquid CDx) | Foundation Medicine, Inc. | Massachusetts | Approved | PMA 135-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190032S030) |
| August 12, 2026 | P170019/S064 | FoundationOne CDx | Foundation Medicine, Inc. | Massachusetts | Approved | PMA 135-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170019S064) |
| August 12, 2026 | K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262792) |
| August 7, 2026 | P190006/S113 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190006S113) |
| August 7, 2026 | P180046/S113 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180046S113) |
| August 6, 2026 | K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | MYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261059) |
| August 6, 2026 | K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula... | Mozarc Medical Us, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | FIE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253469) |
| August 5, 2026 | P220014/S012 | CraniSeal Dural Sealant | Pramand, LLC | Massachusetts | Approved | PMA real-time process supplement | NQR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220014S012) |
| August 4, 2026 | K261915 | Navigator™ Flex Ureteral Access Sheath Set | Boston Scientific Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | FED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261915) |
| August 3, 2026 | K261504 | PuraStat-RM | 3-D Matrix, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | PHN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261504) |
| August 3, 2026 | K261503 | PuraStat GI | 3-D Matrix, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | QAU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261503) |
| July 31, 2026 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261451) |
| July 28, 2026 | K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | Massachusetts | Substantially Equivalent | 510(k) traditional | JAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253450) |
| July 24, 2026 | P190006/S110 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA real-time process supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190006S110) |
| July 24, 2026 | P180046/S110 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA real-time process supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180046S110) |
| July 24, 2026 | K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | Massachusetts | Substantially Equivalent | 510(k) special | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262462) |
| July 24, 2026 | K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | KDI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261267) |
| July 24, 2026 | K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser... | Olympus Surgical Technologies America | Massachusetts | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261221) |
| July 23, 2026 | K261853 | Gepotidacin GEP 10 µg | Liofilchem, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | JTN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261853) |
| July 20, 2026 | P200036/S011 | eCoin Peripheral Neurostimulator | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | QPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200036S011) |
| July 16, 2026 | P160015/S028 | AED 3; CPR Uni-Padz | ZOLL Medical Corporation | Massachusetts | Approved | PMA 180-day supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160015S028) |
| July 15, 2026 | P800002/S035 | Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web | C.R. Bard, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P800002S035) |
| July 14, 2026 | P160022/S053 | OneStep CPR Complete Electrodes, OneStep CPR Complete Adult/Child Electrodes, OneStep CPR AA Electrodes... | ZOLL Medical Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160022S053) |
| July 10, 2026 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation | Massachusetts | Substantially Equivalent | 510(k) special | ESW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261978) |
| July 9, 2026 | P220020/S008 | Lava Liquid Embolic System (Lava LES) | Sirtex Medical, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220020S008) |
| July 9, 2026 | K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)... | Smith & Nephew, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261968) |
| July 9, 2026 | K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | QFF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261471) |
| July 6, 2026 | DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. | Massachusetts | Unknown | De Novo | SIQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250037) |
| July 2, 2026 | K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253463) |
| July 1, 2026 | P170023/S024 | Bulkamid Urethral Bulking System | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | LNM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170023S024) |
| June 29, 2026 | K261461 | Omnipod 6 algorithm | Insulet Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | QJI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261461) |
| June 26, 2026 | K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | Massachusetts | Substantially Equivalent | 510(k) traditional | SAN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253316) |
| June 23, 2026 | K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON... | Integra Lifesciences Production Corporation | Massachusetts | Substantially Equivalent | 510(k) traditional | JXG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261004) |
| June 18, 2026 | K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | Massachusetts | Substantially Equivalent | 510(k) special | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261713) |
| June 18, 2026 | K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | Massachusetts | Substantially Equivalent | 510(k) traditional | QAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260729) |
| June 17, 2026 | P190006/S112 | Axonics SNM System | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190006S112) |
| June 17, 2026 | P180046/S112 | Axonics SNM System | Boston Scientific Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180046S112) |
| June 17, 2026 | K261570 | PICOSURE WORKSTATION | Cynosure, LLC | Massachusetts | Substantially Equivalent | 510(k) special | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261570) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Boston Scientific Corporation | 92 | October 13, 2026 |
| ZOLL Medical Corporation | 35 | October 16, 2026 |
| Abiomed, Inc. | 26 | October 26, 2026 |
| Foundation Medicine, Inc. | 18 | September 18, 2026 |
| Pramand, LLC | 17 | October 1, 2026 |
| Instylla, Inc. | 15 | October 23, 2026 |
| Fresenius Medical Care Renal Therapies Group, LLC | 15 | October 19, 2026 |
| Boston Scientific Corp | 14 | September 14, 2026 |
| TransMedics, Inc. | 12 | October 28, 2026 |
| BTL Industries, Inc. | 10 | September 23, 2026 |
| Sirtex Medical, Inc. | 9 | July 9, 2026 |
| DeepHealth, Inc. | 7 | June 15, 2026 |
| Anika Therapeutics, Inc. | 6 | September 17, 2026 |
| Smith & Nephew, Inc. | 5 | October 27, 2026 |
| Hologic, Inc. | 5 | August 12, 2026 |
| LeMaitre Vascular, Inc. | 4 | October 15, 2026 |
| C.R. Bard, Inc. | 4 | September 29, 2026 |
| Boston Scientific | 4 | September 3, 2026 |
| Anumana, Inc. | 4 | June 15, 2026 |
| Instrumentation Laboratory (IL) Co. | 4 | March 20, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 134 | October 28, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 104 | October 26, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 47 | October 13, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 39 | October 28, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 33 | October 1, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 27 | October 23, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 21 | September 18, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 15 | August 31, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 8 | October 28, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 8 | July 23, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 7 | October 27, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 7 | June 29, 2026 |
| [Hematology](https://specstream.ai/data/fda-clearances/panel/hematology) | 7 | March 20, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 6 | October 6, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 5 | September 30, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 5 | August 25, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 5 | December 19, 2025 |
| Unknown | 4 | September 2, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 3 | September 21, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 176 | October 28, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 122 | October 28, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 58 | October 16, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 48 | October 27, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 41 | September 25, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 15 | October 23, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 8 | August 12, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 6 | October 23, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 5 | September 28, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 3 | August 21, 2026 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 3 | January 9, 2026 |

## 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/).