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Data / FDA device clearances / Florida

FDA device clearances in Florida: 301 since Nov 2024

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. The list gains about 11 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/florida, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

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 request: Every new FDA device clearance or approval for a company in Florida, 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.

  • 301Decisions
  • 205510(k) and De Novo
  • 96PMA
  • October 30, 2026Latest decision

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 dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 30, 2026K263075Strauss Surgical Cystoscope/Hysteroscope and Accessories InstrumentsStrauss Surgical USAFloridaSubstantially Equivalent510(k) traditionalFAJaccessdata.fda.gov
October 29, 2026K263602Arthrex Plates, Screws and Pins, and WashersArthrex, Inc.FloridaSubstantially Equivalent510(k) specialHRSaccessdata.fda.gov
October 28, 2026P200045/S025RelayPro Thoracic Stent-Graft Delivery SystemBolton Medical, Inc.Florida30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
October 27, 2026K263477Arthrex FiberButtonArthrex, Inc.FloridaSubstantially Equivalent510(k) specialMBIaccessdata.fda.gov
October 26, 2026K261135Trochlear Salvage Plating SystemSkeletal Dynamics, Inc.FloridaSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
October 23, 2026P990040/S037TRUFILL n-BCA Liquid Embolic SystemCerenovus, Inc.FloridaApprovedPMA 180-day supplementKGGaccessdata.fda.gov
October 23, 2026P200020/S013ClearView™ HD intraocular lens (IOL)Lenstec, Inc.FloridaApprovedPMA 180-day supplementMFKaccessdata.fda.gov
October 21, 2026K252736Hemotag Analysis Software (HAS)Aventusoft, LLCFloridaSubstantially Equivalent510(k) traditionalDQDaccessdata.fda.gov
October 16, 2026P040045/S147VISTAKON® (senofilcon A) Brand Contact LensesVistakon, Division of Johnson & Johnson Vision CarFlorida30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
October 15, 2026P120002/S036S.M.A.R.T. and S.M.A.R.T. ® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent SystemCordis US CorporationFlorida30-day notice acceptedPMA 30-day noticeNIPaccessdata.fda.gov
October 15, 2026P020036/S061S.M.A.R.T. ® CONTROL® Nitinol Stent SystemCordis US CorporationFlorida30-day notice acceptedPMA 30-day noticeNIOaccessdata.fda.gov
October 15, 2026K260530epi-ConneKt™ Wound MatrixMLM Biologics, Inc.FloridaSubstantially Equivalent510(k) traditionalKGNaccessdata.fda.gov
October 14, 2026K263208Vantage Lumbar Decompression KitSurGenTec, LLCFloridaSubstantially Equivalent510(k) specialHRXaccessdata.fda.gov
October 13, 2026K261321Yomi S Robotic SystemNeocis, Inc.FloridaSubstantially Equivalent510(k) traditionalQRYaccessdata.fda.gov
October 9, 2026K261521Sleep Analysis ModuleNeurotronics, LLCFloridaSubstantially Equivalent510(k) traditionalOLZaccessdata.fda.gov
October 8, 2026P040045/S146VISTAKON (SENOFILCON A) Brand Contact LensesVistakon, Division of Johnson & Johnson Vision CarFlorida30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
October 7, 2026K262134NeuroDRDeep Reasoning Ai, Inc.FloridaSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
October 2, 2026K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLCFloridaSubstantially Equivalent510(k) specialKTTaccessdata.fda.gov
September 25, 2026K262975Arthrex Beaming SystemArthrex, Inc.FloridaSubstantially Equivalent510(k) specialHWCaccessdata.fda.gov
September 24, 2026K262618Arthrex Spine Compression FT ScrewArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalMRWaccessdata.fda.gov
September 22, 2026K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLCFloridaSubstantially Equivalent510(k) traditionalPBXaccessdata.fda.gov
September 21, 2026K260940BellaTek BarsZimVie US Corp, LLCFloridaSubstantially Equivalent510(k) specialNHAaccessdata.fda.gov
September 17, 2026K252995Durashield Device KitSurGenTec, LLCFloridaSubstantially Equivalent510(k) traditionalGZTaccessdata.fda.gov
September 15, 2026K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.FloridaSubstantially Equivalent510(k) specialHRSaccessdata.fda.gov
September 14, 2026K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System...Xenix MedicalFloridaSubstantially Equivalent510(k) traditionalNKBaccessdata.fda.gov
September 4, 2026K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking...Medtronic Xomed, Inc.FloridaSubstantially Equivalent510(k) traditionalPGWaccessdata.fda.gov
September 4, 2026K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,FloridaSubstantially Equivalent510(k) traditionalEZLaccessdata.fda.gov
September 2, 2026P040045/S145VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKERVistakon, Division of Johnson & Johnson Vision CarFlorida30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
September 2, 2026K260432Ruby Intravascular CatheterVenocare, Inc.FloridaSubstantially Equivalent510(k) traditionalFOZaccessdata.fda.gov
September 1, 2026K262451Arthrex DynaNite StaplesArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalJDRaccessdata.fda.gov
August 26, 2026K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCFloridaSubstantially Equivalent510(k) specialFMFaccessdata.fda.gov
August 24, 2026K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLCFloridaSubstantially Equivalent510(k) traditionalOURaccessdata.fda.gov
August 21, 2026K261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsApyx Medical CorporationFloridaSubstantially Equivalent510(k) traditionalQPBaccessdata.fda.gov
August 21, 2026DEN250026AvuluxMatap Ii, LLCFloridaUnknownDe NovoQEOaccessdata.fda.gov
August 18, 2026K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.FloridaSubstantially Equivalent510(k) traditionalHIHaccessdata.fda.gov
August 17, 2026K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual...KLS-Martin L.P.FloridaSubstantially Equivalent510(k) traditionalJEYaccessdata.fda.gov
August 14, 2026K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.FloridaSubstantially Equivalent510(k) traditionalMWIaccessdata.fda.gov
August 13, 2026K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.FloridaSubstantially Equivalent510(k) specialNRYaccessdata.fda.gov
August 13, 2026K261061BP Go (BPP-855)Wellvii, Inc.FloridaSubstantially Equivalent510(k) traditionalDXNaccessdata.fda.gov
August 7, 2026K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.FloridaSubstantially Equivalent510(k) specialMAIaccessdata.fda.gov
August 7, 2026K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)FloridaSubstantially Equivalent510(k) traditionalNUCaccessdata.fda.gov
July 30, 2026K260624Arthrex Radial Head Replacement SystemArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalKWIaccessdata.fda.gov
July 30, 2026K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.FloridaSubstantially Equivalent510(k) traditionalLDFaccessdata.fda.gov
July 29, 2026K261770Suture Button Repair SystemSkeletal Dynamics, Inc.FloridaSubstantially Equivalent510(k) traditionalMBIaccessdata.fda.gov
July 28, 2026K261399ELISIO™-HXNipro Medical CorporationFloridaSubstantially Equivalent510(k) traditionalQAXaccessdata.fda.gov
July 27, 2026P020016/S010Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc.FloridaApprovedPMA 180-day supplementaccessdata.fda.gov
July 24, 2026K262121Ion-L Navigated InstrumentsSurGenTec, LLCFloridaSubstantially Equivalent510(k) specialOLOaccessdata.fda.gov
July 24, 2026K261312Temporary Keratoprosthesis (QuickSet TKP™)Eyekon Medical, Inc.FloridaSubstantially Equivalent510(k) traditionalMLPaccessdata.fda.gov
July 23, 2026K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.FloridaSubstantially Equivalent510(k) specialNBWaccessdata.fda.gov
July 15, 2026K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.FloridaSubstantially Equivalent510(k) traditionalPLRaccessdata.fda.gov
July 10, 2026K262120Avara ViewerAvara SoftwareFloridaSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
June 26, 2026K260018Arthrex FiberButtonArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalMBIaccessdata.fda.gov
June 26, 2026K253306BioTracker 2.0Biotracker, LLCFloridaSubstantially Equivalent510(k) traditionalaccessdata.fda.gov
June 25, 2026K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalHWCaccessdata.fda.gov
June 23, 2026P100013/S034Exoseal Vascular Closure DeviceCordis US CorporationFloridaApprovedPMA special supplementMGBaccessdata.fda.gov
June 18, 2026P200045/S024RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.Florida30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
June 18, 2026P190015/S030TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.Florida30-day notice acceptedPMA 30-day noticeMIHaccessdata.fda.gov
June 17, 2026K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.FloridaSubstantially Equivalent510(k) traditionalLJTaccessdata.fda.gov
June 15, 2026K260126Curajel™ Oral GelUSpharma, Ltd.FloridaSubstantially Equivalent510(k) traditionalOLRaccessdata.fda.gov
June 11, 2026K261209Ion-LSurGenTec, LLCFloridaSubstantially Equivalent510(k) traditionalMRWaccessdata.fda.gov
June 8, 2026K251944Lipocosm Harmonic SystemLipocosm, LLCFloridaSubstantially Equivalent510(k) traditionalQPBaccessdata.fda.gov
June 5, 2026P030047/S055PRECISE PRO RX Nitinol Stent SystemCordis US CorporationFloridaApprovedPMA special supplementNIMaccessdata.fda.gov
June 5, 2026K253204CatalyzeBioTissue Holdings, Inc.FloridaSubstantially Equivalent510(k) traditionalKGNaccessdata.fda.gov
June 4, 2026K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.FloridaSubstantially Equivalent510(k) traditionalHIHaccessdata.fda.gov
June 3, 2026K261484Tissue Approximation SystemTas Medical, Inc.FloridaSubstantially Equivalent510(k) specialGARaccessdata.fda.gov
June 2, 2026K261002Pectus Blu SystemBiomet MicrofixationFloridaSubstantially Equivalent510(k) traditionalHRSaccessdata.fda.gov
June 2, 2026K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLCFloridaSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
May 28, 2026K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalMAIaccessdata.fda.gov
May 28, 2026K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.FloridaSubstantially Equivalent510(k) traditionalGZJaccessdata.fda.gov
May 26, 2026P990040/S038TRUFILL n-BCA Liquid Embolic SystemCerenovus, Inc.Florida30-day notice acceptedPMA 30-day noticeKGGaccessdata.fda.gov
May 22, 2026K260329Ion-C Navigation InstrumentsSurGenTec, LLCFloridaSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
May 14, 2026P040044/S113Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Venous Vascular ClosureCordis US CorporationFloridaApprovedPMA special supplementMGBaccessdata.fda.gov
May 12, 2026K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.FloridaSubstantially Equivalent510(k) traditionalODPaccessdata.fda.gov
May 8, 2026K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLCFloridaSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
May 8, 2026K254215Arthrex Beaming SystemArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalHWCaccessdata.fda.gov
May 8, 2026K253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical CorporationFloridaSubstantially Equivalent510(k) traditionalQPBaccessdata.fda.gov
May 4, 2026P040045/S144VISTAKON® (senofilcon A) contact lensesVistakon, Division of Johnson & Johnson Vision CarFlorida30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
April 29, 2026P040045/S143VISTAKON® (senofilcon A) Contact LensesVistakon, Division of Johnson & Johnson Vision CarFlorida30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
April 29, 2026K252471Paptizer 360LiViliti Health Products CorporationFloridaSubstantially Equivalent510(k) traditionalQXQaccessdata.fda.gov
April 23, 2026K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCFloridaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
April 17, 2026P040045/S142VISTAKON® (senofilcon A) Brand Contact LensesVistakon, Division of Johnson & Johnson Vision CarFlorida30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
April 17, 2026N18033/S114VISTAKON® (etafilcon A) Brand Contact LensesVistakon, Johnson & Johnson Vision Products, Inc.Florida30-day notice acceptedPMA 30-day noticeLPMaccessdata.fda.gov
April 16, 2026K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°...Strauss Surgical USAFloridaSubstantially Equivalent510(k) traditionalFAJaccessdata.fda.gov
April 15, 2026P200020/S012Clearview 3Lenstec, Inc.Florida30-day notice acceptedPMA 30-day noticeMFKaccessdata.fda.gov
April 15, 2026P090022/S049Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDMLenstec, Inc.Florida30-day notice acceptedPMA 30-day noticeHQLaccessdata.fda.gov
April 14, 2026K260583Equinoxe® Shoulder SystemExactech, Inc.FloridaSubstantially Equivalent510(k) traditionalPHXaccessdata.fda.gov
April 13, 2026P200045/S017RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc.FloridaApprovedPMA 180-day supplementMIHaccessdata.fda.gov
April 13, 2026P190015/S024TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.FloridaApprovedPMA 180-day supplementMIHaccessdata.fda.gov
April 13, 2026K260340HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT...HC Biologics, LLCFloridaSubstantially Equivalent510(k) traditionalODPaccessdata.fda.gov
April 7, 2026K254191IWD-Gel™InnovaCorium, Inc.FloridaSubstantially Equivalent510(k) traditionalFROaccessdata.fda.gov
April 3, 2026DEN240071neuropacsAutomated Imaging Diagnostics, LLCFloridaUnknownDe NovoSHOaccessdata.fda.gov
March 31, 2026P040044/S111Mynx Control Vascular Closure Device (5F, 6F/7F)Cordis US CorporationFlorida30-day notice acceptedPMA 30-day noticeMGBaccessdata.fda.gov
March 27, 2026K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.FloridaSubstantially Equivalent510(k) traditionalFAJaccessdata.fda.gov
March 26, 2026P190015/S026TREO® Abdominal Stent-Graft SystemBolton Medical, Inc.FloridaApprovedPMA 180-day supplementMIHaccessdata.fda.gov
March 25, 2026P200020/S011ClearView 3 IOLLenstec, Inc.FloridaApprovedPMA real-time process supplementMFKaccessdata.fda.gov
March 24, 2026K253047PRESSONE™Nipro Medical CorporationFloridaSubstantially Equivalent510(k) traditionalFMIaccessdata.fda.gov
March 23, 2026K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.FloridaSubstantially Equivalent510(k) abbreviatedHRSaccessdata.fda.gov
March 20, 2026K260561Arthrex FiberTak Suture AnchorArthrex, Inc.FloridaSubstantially Equivalent510(k) specialMBIaccessdata.fda.gov
March 20, 2026K253604TiLink-L Navigation InstrumentsSurGenTec, LLCFloridaSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
March 20, 2026K252016Arthrex Humeral NailsArthrex, Inc.FloridaSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Arthrex, Inc.41October 29, 2026
Cordis US Corporation38October 15, 2026
Bolton Medical, Inc.21October 28, 2026
SurGenTec, LLC17October 14, 2026
Vistakon, Division of Johnson & Johnson Vision Car9October 16, 2026
Lenstec, Inc.8October 23, 2026
Cerenovus, Inc.6October 23, 2026
Skeletal Dynamics, Inc.5October 26, 2026
KLS-Martin L.P.5August 17, 2026
Exactech, Inc.5April 14, 2026
Axora Medical, Inc.4August 18, 2026
Atlas Spine, Inc.4July 15, 2026
Rebotix4August 20, 2025
Neocis, Inc.3October 13, 2026
Venocare, Inc.3September 2, 2026
Apyx Medical Corporation3August 21, 2026
Nipro Medical Corporation3July 28, 2026
American Medical Endoscopy, Inc.3June 4, 2026
Vistakon, Johnson & Johnson Vision Products, Inc.3April 17, 2026
InspireMD, Ltd.3March 16, 2026

By panel

PanelDecisionsLatest
Orthopedic92October 29, 2026
Cardiovascular70October 28, 2026
Ophthalmic22October 23, 2026
Neurology21October 23, 2026
General, Plastic Surgery20September 22, 2026
Gastroenterology, Urology16October 30, 2026
Unknown12October 15, 2026
Radiology11October 7, 2026
Dental9October 13, 2026
General Hospital9September 2, 2026
Obstetrics/Gynecology7August 18, 2026
Microbiology3February 5, 2026
Physical Medicine3July 18, 2025
Clinical Chemistry2July 23, 2026
Anesthesiology1April 23, 2026
Ear, Nose, Throat1February 10, 2026
Hematology1September 10, 2025
Immunology1July 25, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional161October 30, 2026
PMA 30-day notice65October 28, 2026
510(k) special41October 29, 2026
PMA 180-day supplement13October 23, 2026
PMA special supplement9June 23, 2026
PMA real-time process supplement6March 25, 2026
De Novo2August 21, 2026
PMA panel track supplement2December 16, 2025
510(k) abbreviated1March 23, 2026
PMA original approval1June 23, 2025

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.