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Data / FDA device clearances / Georgia

FDA device clearances in Georgia: 94 since Nov 2024

The full list. FDA device clearances for applicants in Georgia: 94 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 4 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.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/georgia, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 28, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 94 device decisions for applicants in Georgia from November 15, 2024 to October 28, 2026: 66 510(k) clearances and De Novo grants and 28 PMA approvals and supplements, for 39 applicants. The newest, K261628 on October 28, 2026, is LymphaTech Mobile 3D Measuring Tool from Lymphatech, Inc..

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

  • 94Decisions
  • 66510(k) and De Novo
  • 28PMA
  • October 28, 2026Latest decision

Newest decisions

The newest 94 of 94, 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 28, 2026K261628LymphaTech Mobile 3D Measuring ToolLymphatech, Inc.GeorgiaSubstantially Equivalent510(k) traditionalOBHaccessdata.fda.gov
October 28, 2026K260310HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown...O&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalQSOaccessdata.fda.gov
October 14, 2026K262432CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid...CorDx, Inc.GeorgiaSubstantially Equivalent510(k) traditionalSCAaccessdata.fda.gov
October 7, 2026K262368B. anthracis Real-time PCR AssayCenters for Disease Control and PreventionGeorgiaSubstantially Equivalent510(k) traditionalNHTaccessdata.fda.gov
October 2, 2026K253422OAB Delivery CatheterCognition Medical Corp.GeorgiaSubstantially Equivalent510(k) traditionalQJPaccessdata.fda.gov
September 30, 2026P100045/S093CardioMEMS PA Sensor and Delivery SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
September 30, 2026P100045/S091CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Application (Model...Abbott MedicalGeorgiaApprovedPMA real-time process supplementMOMaccessdata.fda.gov
September 30, 2026K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A...Centers for Disease Control and PreventionGeorgiaSubstantially Equivalent510(k) specialOZEaccessdata.fda.gov
September 23, 2026K260995DynaNail Helix® Fixation SystemMedShape, Inc.GeorgiaSubstantially Equivalent510(k) traditionalHWCaccessdata.fda.gov
September 11, 2026P100045/S092CardioMEMS PA Sensor and Delivery System (CM2000); CardioMEMS™ HF SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
August 14, 2026K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.GeorgiaSubstantially Equivalent510(k) traditionalOBPaccessdata.fda.gov
August 10, 2026K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety...Hh Global Technology, Inc.GeorgiaSubstantially Equivalent510(k) specialFMIaccessdata.fda.gov
August 4, 2026P000037/S071On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (On-X AAP)On-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
July 27, 2026P000037/S070On-X Prosthetic Heart Valves and Ascending Aortic ProthesisOn-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
July 21, 2026K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) specialLZAaccessdata.fda.gov
July 15, 2026P010003/S043BioGlue® Surgical AdhesiveCryolife, Inc.GeorgiaApprovedPMA real-time process supplementMUQaccessdata.fda.gov
July 10, 2026K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric...C.R. Bard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalKNTaccessdata.fda.gov
July 2, 2026K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap...O&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalFRGaccessdata.fda.gov
June 26, 2026P250055AMDS Hybrid ProsthesisArtivion, Inc.GeorgiaApprovedPMA original approvalQSKaccessdata.fda.gov
June 25, 2026K253274BedDot (G1)Intelligent Dots, LLCGeorgiaSubstantially Equivalent510(k) traditionalBZQaccessdata.fda.gov
June 18, 2026K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.GeorgiaSubstantially Equivalent510(k) traditionalMWJaccessdata.fda.gov
June 1, 2026P100045/S090CardioMEMS HF SystemAbbott MedicalGeorgiaApprovedPMA 180-day supplementMOMaccessdata.fda.gov
June 1, 2026K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.GeorgiaSubstantially EquivalentDe Novo (dual track)QVFaccessdata.fda.gov
May 29, 2026K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.GeorgiaUnknown510(k) traditionalFCMaccessdata.fda.gov
May 18, 2026K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL...O&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalFRGaccessdata.fda.gov
May 13, 2026P100045/S089CardioMEMS™ HF SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
April 16, 2026K254101Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc.GeorgiaSubstantially Equivalent510(k) traditionalNUCaccessdata.fda.gov
April 10, 2026K253917ARION ARC SystemPlasma Surgical, Inc.GeorgiaSubstantially Equivalent510(k) traditionalGEIaccessdata.fda.gov
April 9, 2026K260317Artelon Convenience KitsInternational Life SciencesGeorgiaSubstantially Equivalent510(k) traditionalQWJaccessdata.fda.gov
March 30, 2026K260812Francisella tularensis Real-time PCR AssayCenters for Disease Control and PreventionGeorgiaSubstantially Equivalent510(k) specialSGAaccessdata.fda.gov
March 30, 2026K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum SpineGeorgiaSubstantially Equivalent510(k) traditionalODPaccessdata.fda.gov
March 25, 2026P100045/S088CardioMEMS™ HF SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
March 18, 2026K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc.GeorgiaSubstantially Equivalent510(k) traditionalHWCaccessdata.fda.gov
March 18, 2026K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLCGeorgiaSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
March 18, 2026K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD*...O&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalFXXaccessdata.fda.gov
March 17, 2026K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)C.R. Bard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalGEXaccessdata.fda.gov
February 27, 2026P100045/S086Next Gen Patient System – CM1200 CardioMEMS HERO DeviceAbbott MedicalGeorgiaApprovedPMA 180-day supplementMOMaccessdata.fda.gov
February 23, 2026K251864Rubber Utility CatheterC.R. Bard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalKODaccessdata.fda.gov
February 19, 2026K260218LacertaMatrixLacerta Life SciencesGeorgiaSubstantially Equivalent510(k) specialKGNaccessdata.fda.gov
February 19, 2026K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLCGeorgiaSubstantially Equivalent510(k) traditionalPLFaccessdata.fda.gov
January 9, 2026P100045/S082CardioMEMS™ HF SystemAbbott MedicalGeorgiaApprovedPMA 135-day supplementMOMaccessdata.fda.gov
January 7, 2026K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.GeorgiaSubstantially Equivalent510(k) specialBZDaccessdata.fda.gov
January 6, 2026K252886Pen NeedleHh Global Technology, Inc.GeorgiaSubstantially Equivalent510(k) traditionalFMIaccessdata.fda.gov
January 5, 2026P000037/S068On-X Prosthetic Heart Valves and Ascending Aortic ProthesisOn-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
December 22, 2025K253339TheracorStimlabs, LLCGeorgiaSubstantially Equivalent510(k) traditionalKGNaccessdata.fda.gov
December 22, 2025K252068MC2 Portable X-ray SystemOxos MedicalGeorgiaSubstantially Equivalent510(k) traditionalOWBaccessdata.fda.gov
December 17, 2025P000037/S067On-X Ascending Aortic ProsthesisOn-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
December 15, 2025K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.GeorgiaSubstantially Equivalent510(k) traditionalLKFaccessdata.fda.gov
December 15, 2025K250319MFUSE (MS001)Machina Medical, Inc.GeorgiaSubstantially Equivalent510(k) traditionalQSYaccessdata.fda.gov
December 11, 2025K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalFXXaccessdata.fda.gov
December 10, 2025K252497SANSA HSATHuxley MedicalGeorgiaSubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
December 9, 2025K250742Focused Cryotherapy SystemFocused Cryo, Inc.GeorgiaSubstantially Equivalent510(k) traditionalGEHaccessdata.fda.gov
December 5, 2025K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use...Dornier Medtech America Inc (Dmta)GeorgiaSubstantially Equivalent510(k) traditionalFASaccessdata.fda.gov
November 20, 2025K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02...Remington Medical, Inc.GeorgiaSubstantially Equivalent510(k) traditionalDPWaccessdata.fda.gov
November 14, 2025DEN250015Neurolyser XR (NXR100)Fusmobile, Inc.GeorgiaUnknownDe NovoSGNaccessdata.fda.gov
November 10, 2025P100045/S087CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model...Abbott MedicalGeorgiaApprovedPMA real-time process supplementMOMaccessdata.fda.gov
October 29, 2025K250882SANSA HSATHuxley MedicalGeorgiaSubstantially Equivalent510(k) traditionalMNRaccessdata.fda.gov
October 24, 2025K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.GeorgiaSubstantially Equivalent510(k) specialMAXaccessdata.fda.gov
October 22, 2025P000037/S066On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP)On-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
October 22, 2025P000037/S065On-X Prosthetic Heart Valves and Ascending Aortic ProthesisOn-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
October 22, 2025P000037/S064On-X Prosthetic Heart Valves; On-X Ascending Aortic ProthesisOn-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
October 22, 2025P000037/S063On-X Heart Valve; On-X Ascending Aortic ProsthesisOn-X Life Technologies, Inc.Georgia30-day notice acceptedPMA 30-day noticeLWQaccessdata.fda.gov
October 2, 2025K252059CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)Artivion, Inc.GeorgiaSubstantially Equivalent510(k) specialOHAaccessdata.fda.gov
September 30, 2025K252072Francisella tularensis Real-time PCR assayCenters for Disease Control and PreventionGeorgiaSubstantially Equivalent510(k) traditionalSGAaccessdata.fda.gov
September 24, 2025P100045/S079CardioMEMS HF SystemAbbott MedicalGeorgiaApprovedPMA special supplementMOMaccessdata.fda.gov
September 17, 2025P100045/S085CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
September 12, 2025K250628DynaNail TTC Fusion SystemMedShape, Inc.GeorgiaSubstantially Equivalent510(k) traditionalHSBaccessdata.fda.gov
September 10, 2025P100045/S084CardioMEMSTM HF SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
August 18, 2025K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with...O&M Halyard, Inc.GeorgiaSubstantially Equivalent510(k) abbreviatedLZAaccessdata.fda.gov
July 29, 2025K243407Forcyte Autograft Harvest KitForcyte Medical, LLCGeorgiaSubstantially Equivalent510(k) traditionalKNWaccessdata.fda.gov
July 28, 2025P100045/S083CardioMEMS HF SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
July 22, 2025K251255LymphaTech Mobile 3D Measuring ToolLymphatech, Inc.GeorgiaSubstantially Equivalent510(k) traditionalSFGaccessdata.fda.gov
July 11, 2025K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)Caire, Inc.GeorgiaSubstantially Equivalent510(k) traditionalCAWaccessdata.fda.gov
July 11, 2025K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A...Centers for Disease Control and PreventionGeorgiaSubstantially Equivalent510(k) traditionalOZEaccessdata.fda.gov
May 15, 2025P100045/S081CardioMEMS HF SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
May 15, 2025K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.GeorgiaSubstantially Equivalent510(k) specialLDFaccessdata.fda.gov
April 17, 2025K243460Ultimate rTMSBrain Ultimate, Inc.GeorgiaSubstantially Equivalent510(k) traditionalOBPaccessdata.fda.gov
April 17, 2025K243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.GeorgiaSubstantially Equivalent510(k) traditionalQCIaccessdata.fda.gov
April 4, 2025K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.GeorgiaSubstantially Equivalent510(k) traditionalMAXaccessdata.fda.gov
April 2, 2025K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.GeorgiaSubstantially Equivalent510(k) traditionalJXIaccessdata.fda.gov
March 26, 2025K243891EarliPoint SystemEarlitec DiagnosticsGeorgiaSubstantially Equivalent510(k) specialQPFaccessdata.fda.gov
March 18, 2025P010003/S042BioGlue® Surgical AdhesiveCryolife, Inc.GeorgiaApprovedPMA 180-day supplementMUQaccessdata.fda.gov
March 14, 2025K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A...Centers for Disease Control and PreventionGeorgiaSubstantially Equivalent510(k) traditionalOZEaccessdata.fda.gov
February 28, 2025K243436Seclusion CatheterBasis MedicalGeorgiaSubstantially Equivalent510(k) traditionalDQYaccessdata.fda.gov
February 6, 2025P100045/S077CardioMEMS HF SystemAbbott MedicalGeorgiaApprovedPMA 180-day supplementMOMaccessdata.fda.gov
January 31, 2025K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140...Dornier Medtech AmericaGeorgiaSubstantially Equivalent510(k) traditionalFEDaccessdata.fda.gov
January 31, 2025K243572Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium...Avanos Medical, Inc.GeorgiaSubstantially Equivalent510(k) specialIRPaccessdata.fda.gov
January 31, 2025K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr....C.R. Bard, Inc.GeorgiaSubstantially Equivalent510(k) traditionalLDFaccessdata.fda.gov
January 28, 2025K244027SANSA HSATHuxley MedicalGeorgiaSubstantially Equivalent510(k) specialMNRaccessdata.fda.gov
December 6, 2024P100045/S080CardioMEMS HF SystemAbbott MedicalGeorgia30-day notice acceptedPMA 30-day noticeMOMaccessdata.fda.gov
December 6, 2024K241567MC2 Portable X-ray SystemOxos MedicalGeorgiaSubstantially Equivalent510(k) traditionalOWBaccessdata.fda.gov
November 22, 2024K242002FemVue MINI Saline-Air DeviceFemasys, Inc.GeorgiaSubstantially Equivalent510(k) traditionalLKFaccessdata.fda.gov
November 19, 2024K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLCGeorgiaSubstantially Equivalent510(k) traditionalNKGaccessdata.fda.gov
November 15, 2024P100045/S078CardioMEMS HF SystemAbbott MedicalGeorgiaApprovedPMA special supplementMOMaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Abbott Medical17September 30, 2026
On-X Life Technologies, Inc.8August 4, 2026
O&M Halyard, Inc.7October 28, 2026
Centers for Disease Control and Prevention6October 7, 2026
C.R. Bard, Inc.6July 10, 2026
MedShape, Inc.3September 23, 2026
Brain Ultimate, Inc.3August 14, 2026
MiRus, LLC3March 18, 2026
Huxley Medical3December 10, 2025
Lymphatech, Inc.2October 28, 2026
CorDx, Inc.2October 14, 2026
Hh Global Technology, Inc.2August 10, 2026
Cryolife, Inc.2July 15, 2026
Artivion, Inc.2June 26, 2026
Oxos Medical2December 22, 2025
Femasys, Inc.2December 15, 2025
Spectrum Spine, Inc.2October 24, 2025
Cognition Medical Corp.1October 2, 2026
Intelligent Dots, LLC1June 25, 2026
Zywie, Inc.1June 18, 2026

By panel

PanelDecisionsLatest
Cardiovascular35October 28, 2026
General, Plastic Surgery8October 28, 2026
Orthopedic8September 23, 2026
Neurology7August 14, 2026
Microbiology6October 14, 2026
General Hospital6August 10, 2026
Gastroenterology, Urology6July 10, 2026
Anesthesiology6June 25, 2026
Unknown4February 19, 2026
Obstetrics/Gynecology3April 16, 2026
Immunology2March 30, 2026
Radiology2December 22, 2025
Physical Medicine1January 31, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional51October 28, 2026
PMA 30-day notice17September 30, 2026
510(k) special12September 30, 2026
PMA 180-day supplement4June 1, 2026
PMA real-time process supplement3September 30, 2026
PMA special supplement2September 24, 2025
PMA original approval1June 26, 2026
De Novo (dual track)1June 1, 2026
PMA 135-day supplement1January 9, 2026
De Novo1November 14, 2025
510(k) abbreviated1August 18, 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.