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Florida FDA 510(k) clearances, last 90 days

US companies with an FDA 510(k) clearance and a Florida address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.

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Last 90 days

30 clearances in the last 90 days. The same 90 days a year earlier: 25.

For contract manufacturers and test labs

Florida had 30 US 510(k) clearances in the last 90 days and 103 in the last 12 months. The product code with the most clearances in this window is HRS (Plate, Fixation, Bone). Contract manufacturers and test labs that sell to device companies in Florida 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 codeDevice typeClearances
HRSPlate, Fixation, Bone3
DQDStethoscope, Electronic1
DXNSystem, Measurement, Blood-Pressure, Non-Invasive1
EZLCatheter, Retention Type, Balloon1
FAJCystoscope And Accessories, Flexible/Rigid1
30 clearances, Aug 2, 2026 to Oct 30, 2026.
Decision dateCompanyDeviceFDA record
Oct 30, 2026Strauss Surgical USAStrauss Surgical Cystoscope/Hysteroscope and Accessories InstrumentsK263075
Oct 29, 2026Arthrex, Inc.Arthrex Plates, Screws and Pins, and WashersK263602
Oct 27, 2026Arthrex, Inc.Arthrex FiberButtonK263477
Oct 26, 2026Skeletal Dynamics, Inc.Trochlear Salvage Plating SystemK261135
Oct 21, 2026Aventusoft, LLCHemotag Analysis Software (HAS)K252736
Oct 14, 2026SurGenTec, LLCVantage Lumbar Decompression KitK263208
Oct 13, 2026Neocis, Inc.Yomi S Robotic SystemK261321
Oct 9, 2026Neurotronics, LLCSleep Analysis ModuleK261521
Oct 7, 2026Deep Reasoning Ai, Inc.NeuroDRK262134
Oct 2, 2026Response Ortho Solutions, LLCResponse Ortho Smart Fixator - Hexapod SystemK263083
Sep 25, 2026Arthrex, Inc.Arthrex Beaming SystemK262975
Sep 22, 2026Bh Group Us, LLCMultiple therapy aesthetic treatment device (BHS 202 UNYQUE)K243223
Sep 21, 2026ZimVie US Corp, LLCBellaTek BarsK260940
Sep 17, 2026SurGenTec, LLCDurashield Device KitK252995
Sep 15, 2026Treace Medical Concepts, Inc.TMC Implant Fixation SystemK262963
Sep 14, 2026Xenix MedicalRIVA Posterior Fixation System with NanoACTIV Surface Technology; RIVA Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyK262193
Sep 4, 2026Medtronic Xomed, Inc.ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)K262235
Sep 4, 2026Sentinel Medical Technologies,TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)K260756
Sep 2, 2026Venocare, Inc.Ruby Intravascular CatheterK260432
Sep 1, 2026Arthrex, Inc.Arthrex DynaNite StaplesK262451
Aug 26, 2026SurGenTec, LLCGraftGun Universal Graft Delivery System (GDS)K262581
Aug 24, 2026SurGenTec, LLCTiLink-L™ SI Joint Fusion SystemK261381
Aug 21, 2026Apyx Medical CorporationAYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsK261710
Aug 18, 2026Axora Medical, Inc.HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)K260984
Aug 17, 2026KLS-Martin L.P.KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsK260137
  • Oct 30, 2026
    Strauss Surgical USA

    Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments

    K263075
  • Oct 29, 2026
    Arthrex, Inc.

    Arthrex Plates, Screws and Pins, and Washers

    K263602
  • Oct 27, 2026
    Arthrex, Inc.

    Arthrex FiberButton

    K263477
  • Oct 26, 2026
    Skeletal Dynamics, Inc.

    Trochlear Salvage Plating System

    K261135
  • Oct 21, 2026
    Aventusoft, LLC

    Hemotag Analysis Software (HAS)

    K252736
  • Oct 14, 2026
    SurGenTec, LLC

    Vantage Lumbar Decompression Kit

    K263208
  • Oct 13, 2026
    Neocis, Inc.

    Yomi S Robotic System

    K261321
  • Oct 9, 2026
    Neurotronics, LLC

    Sleep Analysis Module

    K261521
  • Oct 7, 2026
    Deep Reasoning Ai, Inc.

    NeuroDR

    K262134
  • Oct 2, 2026
    Response Ortho Solutions, LLC

    Response Ortho Smart Fixator - Hexapod System

    K263083
  • Sep 25, 2026
    Arthrex, Inc.

    Arthrex Beaming System

    K262975
  • Sep 22, 2026
    Bh Group Us, LLC

    Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)

    K243223
  • Sep 21, 2026
    ZimVie US Corp, LLC

    BellaTek Bars

    K260940
  • Sep 17, 2026
    SurGenTec, LLC

    Durashield Device Kit

    K252995
  • Sep 15, 2026
    Treace Medical Concepts, Inc.

    TMC Implant Fixation System

    K262963
  • Sep 14, 2026
    Xenix Medical

    RIVA Posterior Fixation System with NanoACTIV Surface Technology; RIVA Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology

    K262193
  • Sep 4, 2026
    Medtronic Xomed, Inc.

    ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)

    K262235
  • Sep 4, 2026
    Sentinel Medical Technologies,

    TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

    K260756
  • Sep 2, 2026
    Venocare, Inc.

    Ruby Intravascular Catheter

    K260432
  • Sep 1, 2026
    Arthrex, Inc.

    Arthrex DynaNite Staples

    K262451
  • Aug 26, 2026
    SurGenTec, LLC

    GraftGun Universal Graft Delivery System (GDS)

    K262581
  • Aug 24, 2026
    SurGenTec, LLC

    TiLink-L™ SI Joint Fusion System

    K261381
  • Aug 21, 2026
    Apyx Medical Corporation

    AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors

    K261710
  • Aug 18, 2026
    Axora Medical, Inc.

    HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)

    K260984
  • Aug 17, 2026
    KLS-Martin L.P.

    KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions

    K260137

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.

FAQ

Is a 510(k) an FDA approval?
No. The FDA clears a device through a 510(k) when it finds the device substantially equivalent to one already sold in the US.
Where do these rows come from?
From openFDA's 510(k) records, for K numbers Whimbrel already holds. Each K number links to the FDA 510(k) database.
Which states get a page?
A state page is published when the state has 10 or more US clearances in the last 12 months and 10 or more in the last 90 days.

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