Massachusetts FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a Massachusetts address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
33 clearances in the last 90 days. The same 90 days a year earlier: 32.
For contract manufacturers and test labs
Massachusetts had 33 US 510(k) clearances in the last 90 days and 113 in the last 12 months. The product code with the most clearances in this window is MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Contract manufacturers and test labs that sell to device companies in Massachusetts can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 |
FIE | Needle, Fistula | 1 |
FPB | Filter, Infusion Line | 1 |
GCJ | Laparoscope, General & Plastic Surgery | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 28, 2026 | GI Windows Surgical | GI Windows Flexagon Plus OTOLoc System | K261630 |
| Oct 27, 2026 | Smith & Nephew, Inc. | Tendon Anchor | K263461 |
| Oct 23, 2026 | Smith & Nephew, Inc. | Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT | K263348 |
| Oct 19, 2026 | Fresenius Medical Care Renal Therapies Group, LLC | multiFiltratePRO System | K261203 |
| Oct 16, 2026 | Analog Devices | Sensinel Cardiopulmonary Management (CPM) System | K260801 |
| Oct 6, 2026 | NormaTec Industries, LP | Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT) | K261887 |
| Oct 2, 2026 | ZSFab, Inc. | ZSAlign Cervical Interbody System | K263113 |
| Sep 30, 2026 | Revvity, Inc. | Eonis SMA kit | K262893 |
| Sep 29, 2026 | Elucid Bioimaging, Inc. | Elucid FFR-IQ (B.1) | K262015 |
| Sep 23, 2026 | BTL Industries, Inc. | BTL-299-F | K262353 |
| Sep 22, 2026 | Samsung HME America, Inc., dba NeuroLogica Corp. | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | K261125 |
| Sep 21, 2026 | Ironsides Medical, Inc. | OtoCompanion (Version 1.0) | K261725 |
| Sep 18, 2026 | Elucid Bioimaging, Inc. | Elucid PlaqueIQ | K261855 |
| Sep 17, 2026 | Anika Therapeutics, Inc. | Integrity Retractable Implant Inserter (6000127) | K261869 |
| Sep 16, 2026 | Olympus Surgical Technologies America | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | K262877 |
| Sep 16, 2026 | A2z Radiology Ai, Inc. | a2z-Abdo-Triage | K260906 |
| Sep 11, 2026 | Boston Scientific Corporation | SpaceOAR Flex System | K262151 |
| Sep 11, 2026 | The General Hospital Corporation, d/b/a Massachusetts | GSPE Spacer | K260063 |
| Sep 3, 2026 | Boston Scientific | Rezum System | K262460 |
| Aug 31, 2026 | Global Life Sciences Solutions USA, LLC | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | K261403 |
| Aug 26, 2026 | Boston Scientific Corporation | LithoVue Elite Digital Flexible Ureteroscope System | K261153 |
| Aug 25, 2026 | Beacon Biosignals, Inc. | Report Studio | K261747 |
| Aug 25, 2026 | Achaemenid, LLC | iNOS intraoral biosensor | K254304 |
| Aug 23, 2026 | BTL Industries, Inc. | BTL-699 | K260691 |
| Aug 20, 2026 | Draeger Medical Systems, Inc. | Infinity Acute Care System (IACS) VG8.1 | K260579 |
| Aug 19, 2026 | Pascall Systems, Inc. | Pascall Sensor Unit (PSU1) | K254213 |
| Aug 16, 2026 | FIND Surgical Sciences Inc. D/B/A FIND Neuro | CN-Suite | K260563 |
| Aug 13, 2026 | Freyja Healthcare, LLC | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | K261139 |
| Aug 13, 2026 | Covidien LP | BIS Advance pEEG Module | K260907 |
| Aug 12, 2026 | Hologic, Inc. | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | K262792 |
| Aug 6, 2026 | Overjet, Inc. | Overjet Multi-Image Caries and Charting Assist | K261059 |
| Aug 6, 2026 | Mozarc Medical Us, LLC | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | K253469 |
| Aug 3, 2026 | 3-D Matrix, Inc. | PuraStat GI | K261503 |
- Oct 28, 2026GI Windows Surgical
GI Windows Flexagon Plus OTOLoc System
- Oct 27, 2026Smith & Nephew, Inc.
Tendon Anchor
- Oct 23, 2026Smith & Nephew, Inc.
Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT
- Oct 19, 2026Fresenius Medical Care Renal Therapies Group, LLC
multiFiltratePRO System
- Oct 16, 2026Analog Devices
Sensinel Cardiopulmonary Management (CPM) System
- Oct 6, 2026NormaTec Industries, LP
Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)
- Oct 2, 2026ZSFab, Inc.
ZSAlign Cervical Interbody System
- Sep 30, 2026Revvity, Inc.
Eonis SMA kit
- Sep 29, 2026Elucid Bioimaging, Inc.
Elucid FFR-IQ (B.1)
- Sep 23, 2026BTL Industries, Inc.
BTL-299-F
- Sep 22, 2026Samsung HME America, Inc., dba NeuroLogica Corp.
BodyTom 64 (NL4100); OmniTom Elite (NL5000)
- Sep 21, 2026Ironsides Medical, Inc.
OtoCompanion (Version 1.0)
- Sep 18, 2026Elucid Bioimaging, Inc.
Elucid PlaqueIQ
- Sep 17, 2026Anika Therapeutics, Inc.
Integrity Retractable Implant Inserter (6000127)
- Sep 16, 2026Olympus Surgical Technologies America
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- Sep 16, 2026A2z Radiology Ai, Inc.
a2z-Abdo-Triage
- Sep 11, 2026Boston Scientific Corporation
SpaceOAR Flex System
- Sep 11, 2026The General Hospital Corporation, d/b/a Massachusetts
GSPE Spacer
- Sep 3, 2026Boston Scientific
Rezum System
- Aug 31, 2026Global Life Sciences Solutions USA, LLC
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
- Aug 26, 2026Boston Scientific Corporation
LithoVue Elite Digital Flexible Ureteroscope System
- Aug 25, 2026Beacon Biosignals, Inc.
Report Studio
- Aug 25, 2026Achaemenid, LLC
iNOS intraoral biosensor
- Aug 23, 2026BTL Industries, Inc.
BTL-699
- Aug 20, 2026Draeger Medical Systems, Inc.
Infinity Acute Care System (IACS) VG8.1
- Aug 19, 2026Pascall Systems, Inc.
Pascall Sensor Unit (PSU1)
- Aug 16, 2026FIND Surgical Sciences Inc. D/B/A FIND Neuro
CN-Suite
- Aug 13, 2026Freyja Healthcare, LLC
VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- Aug 13, 2026Covidien LP
BIS Advance pEEG Module
- Aug 12, 2026Hologic, Inc.
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
- Aug 6, 2026Overjet, Inc.
Overjet Multi-Image Caries and Charting Assist
- Aug 6, 2026Mozarc Medical Us, LLC
Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)
- Aug 3, 20263-D Matrix, Inc.
PuraStat GI
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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