Decisions39
Applicants27
39 premarket notifications (510(k)s) from applicants based in Georgia were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-10-02 | Cognition Medical Corp. | OAB Delivery Catheter QJP | Cardiovascular | Atlanta, Georgia | K253422 |
| 2026-09-30 | Centers for Disease Control and Prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) OZE | Microbiology | Atlanta, Georgia | K263035 |
| 2026-09-23 | MedShape, Inc. | DynaNail Helix® Fixation System HWC | Orthopedic | Atlanta, Georgia | K260995 |
| 2026-08-14 | Brain Ultimate, Inc. | QuickVision Ultimate rTMS OBP | Neurology | Alpharetta, Georgia | K261228 |
| 2026-08-10 | Hh Global Technology, Inc. | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) FMI | General Hospital | Buford, Georgia | K262427 |
| 2026-07-21 | O&M Halyard, Inc. | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves LZA | General Hospital | Alpharetta, Georgia | K262014 |
| 2026-07-10 | C.R. Bard, Inc. | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) KNT | Gastroenterology, Urology | Covington, Georgia | K253514 |
| 2026-07-02 | O&M Halyard, Inc. | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology FRG | General Hospital | Alpharetta, Georgia | K261897 |
| 2026-06-25 | Intelligent Dots, LLC | BedDot (G1) BZQ | Anesthesiology | Peachtree Corner, Georgia | K253274 |
| 2026-06-18 | Zywie, Inc. | ZywieZ3 Sensor & Adhesive MWJ | Cardiovascular | Johns Creek, Georgia | K252839 |
| 2026-06-01 | CorDx, Inc. | CorDx Tyfast COVID-19 Ag Rapid Test Rx QVF | Microbiology | Alpharetta, Georgia | K253882 |
| 2026-05-29 | C.R. Bard, Inc. | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit FCM | Gastroenterology, Urology | Covington, Georgia | K254076 |
| 2026-05-18 | O&M Halyard, Inc. | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap FRG | General Hospital | Alpharetta, Georgia | K253454 |
| 2026-04-16 | Golden Isles Medical, Inc. | Julva Velvé Water-Based Personal Lubricant NUC | Obstetrics/Gynecology | Brunswick, Georgia | K254101 |
| 2026-04-10 | Plasma Surgical, Inc. | ARION ARC System GEI | General, Plastic Surgery | Roswell, Georgia | K253917 |
| 2026-04-09 | International Life Sciences | Artelon Convenience Kits QWJ | General, Plastic Surgery | Sandy Springs, Georgia | K260317 |
| 2026-03-30 | Spectrum Spine | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System ODP | Orthopedic | Jasper, Georgia | K252240 |
| 2026-03-30 | Centers for Disease Control and Prevention | Francisella tularensis Real-time PCR Assay SGA | Immunology | Atlanta, Georgia | K260812 |
| 2026-03-18 | O&M Halyard, Inc. | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor FXX | General, Plastic Surgery | Alpharetta, Georgia | K251967 |
| 2026-03-18 | MiRus, LLC | EUROPA Posterior Cervical Fusion Navigated Instruments OLO | Neurology | Marietta, Georgia | K253444 |
| 2026-03-18 | MedShape, Inc. | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro HWC | Orthopedic | Atlanta, Georgia | K254110 |
| 2026-03-17 | C.R. Bard, Inc. | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) GEX | General, Plastic Surgery | Covington, Georgia | K252971 |
| 2026-02-23 | C.R. Bard, Inc. | Rubber Utility Catheter KOD | Gastroenterology, Urology | Covington, Georgia | K251864 |
| 2026-02-19 | MiRus, LLC | ATLAS Expandable Osteotomy Wedge System PLF | Orthopedic | Marietta, Georgia | K252733 |
| 2026-02-19 | Lacerta Life Sciences | LacertaMatrix KGN | Unknown | Woodstock, Georgia | K260218 |
| 2026-01-07 | RemSleep Holdings, Inc. | DeltaWave Nasal Pillow System BZD | Anesthesiology | Blackshear, Georgia | K253939 |
| 2026-01-06 | Hh Global Technology, Inc. | Pen Needle FMI | General Hospital | Buford, Georgia | K252886 |
| 2025-12-22 | Oxos Medical | MC2 Portable X-ray System OWB | Radiology | Atlanta, Georgia | K252068 |
| 2025-12-22 | Stimlabs, LLC | Theracor KGN | Unknown | Roswell, Georgia | K253339 |
| 2025-12-15 | Machina Medical, Inc. | MFUSE (MS001) QSY | Unknown | Roswell, Georgia | K250319 |
| 2025-12-15 | Femasys, Inc. | FemVue® Controlled Saline-Air Device (FSA-300) LKF | Obstetrics/Gynecology | Cumming, Georgia | K253403 |
| 2025-12-11 | O&M Halyard, Inc. | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops FXX | General, Plastic Surgery | Alpharetta, Georgia | K252941 |
| 2025-12-10 | Huxley Medical | SANSA HSAT MNR | Anesthesiology | Atlanta, Georgia | K252497 |
| 2025-12-09 | Focused Cryo, Inc. | Focused Cryotherapy System GEH | General, Plastic Surgery | Marietta, Georgia | K250742 |
| 2025-12-05 | Dornier Medtech America Inc (Dmta) | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) FAS | Gastroenterology, Urology | Kennesaw, Georgia | K251403 |
| 2025-11-20 | Remington Medical, Inc. | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) DPW | Cardiovascular | Alpharetta, Georgia | K251904 |
| 2025-11-14 | Fusmobile, Inc. | Neurolyser XR (NXR100) SGN | Neurology | Alpharetta, Georgia | DEN250015 |
| 2025-10-29 | Huxley Medical | SANSA HSAT MNR | Anesthesiology | Atlanta, Georgia | K250882 |
| 2025-10-24 | Spectrum Spine, Inc. | Expandable Titanium PLIF/TLIF System MAX | Orthopedic | Jasper, Georgia | K253377 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
Permanent URL:
https://mentionfox.com/fda/510k/state/gaLast updated 2026-10-18
FDA device clearances in Georgia: 39 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/ga