# FDA device clearances in Georgia: 94 since Nov 2024

Updated October 28, 2026.

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 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. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 4 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/state/georgia

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.

- Decisions: 94
- 510(k) and De Novo: 66
- PMA: 28
- Latest decision: October 28, 2026

## 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 date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 28, 2026 | K261628 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | OBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261628) |
| October 28, 2026 | K260310 | HALYARD\* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD\* Procedure Gown... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | QSO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260310) |
| October 14, 2026 | K262432 | CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid... | CorDx, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | SCA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262432) |
| October 7, 2026 | K262368 | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) traditional | NHT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262368) |
| October 2, 2026 | K253422 | OAB Delivery Catheter | Cognition Medical Corp. | Georgia | Substantially Equivalent | 510(k) traditional | QJP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253422) |
| September 30, 2026 | P100045/S093 | CardioMEMS PA Sensor and Delivery System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S093) |
| September 30, 2026 | P100045/S091 | CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Application (Model... | Abbott Medical | Georgia | Approved | PMA real-time process supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S091) |
| September 30, 2026 | K263035 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A... | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) special | OZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263035) |
| September 23, 2026 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260995) |
| September 11, 2026 | P100045/S092 | CardioMEMS PA Sensor and Delivery System (CM2000); CardioMEMS™ HF System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S092) |
| August 14, 2026 | K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261228) |
| August 10, 2026 | K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety... | Hh Global Technology, Inc. | Georgia | Substantially Equivalent | 510(k) special | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262427) |
| August 4, 2026 | P000037/S071 | On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (On-X AAP) | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S071) |
| July 27, 2026 | P000037/S070 | On-X Prosthetic Heart Valves and Ascending Aortic Prothesis | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S070) |
| July 21, 2026 | K262014 | PUREZERO\* MARIN\* Nitrile Powder-Free Exam Gloves; PUREZERO\* MARIN-XTRA\* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) special | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262014) |
| July 15, 2026 | P010003/S043 | BioGlue® Surgical Adhesive | Cryolife, Inc. | Georgia | Approved | PMA real-time process supplement | MUQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010003S043) |
| July 10, 2026 | K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric... | C.R. Bard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | KNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253514) |
| July 2, 2026 | K261897 | HALYARD\* ARMOR-FLEX\* Sterilization Wrap with ASSURE-DRY\* Technology; HALYARD\* HEAVY-FLEX\* Sterilization Wrap... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | FRG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261897) |
| June 26, 2026 | P250055 | AMDS Hybrid Prosthesis | Artivion, Inc. | Georgia | Approved | PMA original approval | QSK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250055) |
| June 25, 2026 | K253274 | BedDot (G1) | Intelligent Dots, LLC | Georgia | Substantially Equivalent | 510(k) traditional | BZQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253274) |
| June 18, 2026 | K252839 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | MWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252839) |
| June 1, 2026 | P100045/S090 | CardioMEMS HF System | Abbott Medical | Georgia | Approved | PMA 180-day supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S090) |
| June 1, 2026 | K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | Georgia | Substantially Equivalent | De Novo (dual track) | QVF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253882) |
| May 29, 2026 | K254076 | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. | Georgia | Unknown | 510(k) traditional | FCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254076) |
| May 18, 2026 | K253454 | HALYARD\* ONE-STEP\* Sterilization Wrap; HALYARD\* QUICK CHECK\* Sterilization Wrap; HALYARD\* SEQUENTIAL... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | FRG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253454) |
| May 13, 2026 | P100045/S089 | CardioMEMS™ HF System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S089) |
| April 16, 2026 | K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | NUC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254101) |
| April 10, 2026 | K253917 | ARION ARC System | Plasma Surgical, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253917) |
| April 9, 2026 | K260317 | Artelon Convenience Kits | International Life Sciences | Georgia | Substantially Equivalent | 510(k) traditional | QWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260317) |
| March 30, 2026 | K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) special | SGA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260812) |
| March 30, 2026 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | Georgia | Substantially Equivalent | 510(k) traditional | ODP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252240) |
| March 25, 2026 | P100045/S088 | CardioMEMS™ HF System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S088) |
| March 18, 2026 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254110) |
| March 18, 2026 | K253444 | EUROPA™ Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | Georgia | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253444) |
| March 18, 2026 | K251967 | HALYARD\* FLUIDSHIELD\* 3 Fog-Free Procedure Mask with SO SOFT\* Lining and SO SOFT\* Earloops; HALYARD\*... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | FXX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251967) |
| March 17, 2026 | K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252971) |
| February 27, 2026 | P100045/S086 | Next Gen Patient System – CM1200 CardioMEMS HERO Device | Abbott Medical | Georgia | Approved | PMA 180-day supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S086) |
| February 23, 2026 | K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | KOD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251864) |
| February 19, 2026 | K260218 | LacertaMatrix | Lacerta Life Sciences | Georgia | Substantially Equivalent | 510(k) special | KGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260218) |
| February 19, 2026 | K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | Georgia | Substantially Equivalent | 510(k) traditional | PLF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252733) |
| January 9, 2026 | P100045/S082 | CardioMEMS™ HF System | Abbott Medical | Georgia | Approved | PMA 135-day supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S082) |
| January 7, 2026 | K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | Georgia | Substantially Equivalent | 510(k) special | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253939) |
| January 6, 2026 | K252886 | Pen Needle | Hh Global Technology, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252886) |
| January 5, 2026 | P000037/S068 | On-X Prosthetic Heart Valves and Ascending Aortic Prothesis | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S068) |
| December 22, 2025 | K253339 | Theracor | Stimlabs, LLC | Georgia | Substantially Equivalent | 510(k) traditional | KGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253339) |
| December 22, 2025 | K252068 | MC2 Portable X-ray System | Oxos Medical | Georgia | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252068) |
| December 17, 2025 | P000037/S067 | On-X Ascending Aortic Prosthesis | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S067) |
| December 15, 2025 | K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | LKF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253403) |
| December 15, 2025 | K250319 | MFUSE (MS001) | Machina Medical, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | QSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250319) |
| December 11, 2025 | K252941 | HALYARD\* Adult Face Mask with SO SOFT\* Lining and SO SOFT\* Earloops | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | FXX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252941) |
| December 10, 2025 | K252497 | SANSA HSAT | Huxley Medical | Georgia | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252497) |
| December 9, 2025 | K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | GEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250742) |
| December 5, 2025 | K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use... | Dornier Medtech America Inc (Dmta) | Georgia | Substantially Equivalent | 510(k) traditional | FAS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251403) |
| November 20, 2025 | K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02... | Remington Medical, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | DPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251904) |
| November 14, 2025 | DEN250015 | Neurolyser XR (NXR100) | Fusmobile, Inc. | Georgia | Unknown | De Novo | SGN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250015) |
| November 10, 2025 | P100045/S087 | CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model... | Abbott Medical | Georgia | Approved | PMA real-time process supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S087) |
| October 29, 2025 | K250882 | SANSA HSAT | Huxley Medical | Georgia | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250882) |
| October 24, 2025 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | Georgia | Substantially Equivalent | 510(k) special | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253377) |
| October 22, 2025 | P000037/S066 | On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP) | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S066) |
| October 22, 2025 | P000037/S065 | On-X Prosthetic Heart Valves and Ascending Aortic Prothesis | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S065) |
| October 22, 2025 | P000037/S064 | On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S064) |
| October 22, 2025 | P000037/S063 | On-X Heart Valve; On-X Ascending Aortic Prosthesis | On-X Life Technologies, Inc. | Georgia | 30-day notice accepted | PMA 30-day notice | LWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000037S063) |
| October 2, 2025 | K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. | Georgia | Substantially Equivalent | 510(k) special | OHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252059) |
| September 30, 2025 | K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) traditional | SGA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252072) |
| September 24, 2025 | P100045/S079 | CardioMEMS HF System | Abbott Medical | Georgia | Approved | PMA special supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S079) |
| September 17, 2025 | P100045/S085 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S085) |
| September 12, 2025 | K250628 | DynaNail TTC Fusion System | MedShape, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250628) |
| September 10, 2025 | P100045/S084 | CardioMEMSTM HF System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S084) |
| August 18, 2025 | K243604 | Halyard Purple Nitrile-XTRA\* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) abbreviated | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243604) |
| July 29, 2025 | K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | Georgia | Substantially Equivalent | 510(k) traditional | KNW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243407) |
| July 28, 2025 | P100045/S083 | CardioMEMS HF System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S083) |
| July 22, 2025 | K251255 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | SFG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251255) |
| July 11, 2025 | K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250671) |
| July 11, 2025 | K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A... | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) traditional | OZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243274) |
| May 15, 2025 | P100045/S081 | CardioMEMS HF System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S081) |
| May 15, 2025 | K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard, Inc. | Georgia | Substantially Equivalent | 510(k) special | LDF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251186) |
| April 17, 2025 | K243460 | Ultimate rTMS | Brain Ultimate, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | OBP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243460) |
| April 17, 2025 | K243459 | Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | QCI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243459) |
| April 4, 2025 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243074) |
| April 2, 2025 | K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | JXI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242113) |
| March 26, 2025 | K243891 | EarliPoint System | Earlitec Diagnostics | Georgia | Substantially Equivalent | 510(k) special | QPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243891) |
| March 18, 2025 | P010003/S042 | BioGlue® Surgical Adhesive | Cryolife, Inc. | Georgia | Approved | PMA 180-day supplement | MUQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010003S042) |
| March 14, 2025 | K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A... | Centers for Disease Control and Prevention | Georgia | Substantially Equivalent | 510(k) traditional | OZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243931) |
| February 28, 2025 | K243436 | Seclusion Catheter | Basis Medical | Georgia | Substantially Equivalent | 510(k) traditional | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243436) |
| February 6, 2025 | P100045/S077 | CardioMEMS HF System | Abbott Medical | Georgia | Approved | PMA 180-day supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S077) |
| January 31, 2025 | K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140... | Dornier Medtech America | Georgia | Substantially Equivalent | 510(k) traditional | FED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243820) |
| January 31, 2025 | K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium... | Avanos Medical, Inc. | Georgia | Substantially Equivalent | 510(k) special | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243572) |
| January 31, 2025 | K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr.... | C.R. Bard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | LDF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241334) |
| January 28, 2025 | K244027 | SANSA HSAT | Huxley Medical | Georgia | Substantially Equivalent | 510(k) special | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244027) |
| December 6, 2024 | P100045/S080 | CardioMEMS HF System | Abbott Medical | Georgia | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S080) |
| December 6, 2024 | K241567 | MC2 Portable X-ray System | Oxos Medical | Georgia | Substantially Equivalent | 510(k) traditional | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241567) |
| November 22, 2024 | K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | LKF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242002) |
| November 19, 2024 | K242516 | EUROPA™ Posterior Cervical Fusion System | MiRus, LLC | Georgia | Substantially Equivalent | 510(k) traditional | NKG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242516) |
| November 15, 2024 | P100045/S078 | CardioMEMS HF System | Abbott Medical | Georgia | Approved | PMA special supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S078) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Abbott Medical | 17 | September 30, 2026 |
| On-X Life Technologies, Inc. | 8 | August 4, 2026 |
| O&M Halyard, Inc. | 7 | October 28, 2026 |
| Centers for Disease Control and Prevention | 6 | October 7, 2026 |
| C.R. Bard, Inc. | 6 | July 10, 2026 |
| MedShape, Inc. | 3 | September 23, 2026 |
| Brain Ultimate, Inc. | 3 | August 14, 2026 |
| MiRus, LLC | 3 | March 18, 2026 |
| Huxley Medical | 3 | December 10, 2025 |
| Lymphatech, Inc. | 2 | October 28, 2026 |
| CorDx, Inc. | 2 | October 14, 2026 |
| Hh Global Technology, Inc. | 2 | August 10, 2026 |
| Cryolife, Inc. | 2 | July 15, 2026 |
| Artivion, Inc. | 2 | June 26, 2026 |
| Oxos Medical | 2 | December 22, 2025 |
| Femasys, Inc. | 2 | December 15, 2025 |
| Spectrum Spine, Inc. | 2 | October 24, 2025 |
| Cognition Medical Corp. | 1 | October 2, 2026 |
| Intelligent Dots, LLC | 1 | June 25, 2026 |
| Zywie, Inc. | 1 | June 18, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 35 | October 28, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 8 | October 28, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 8 | September 23, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 7 | August 14, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 6 | October 14, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 6 | August 10, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 6 | July 10, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 6 | June 25, 2026 |
| Unknown | 4 | February 19, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 3 | April 16, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 2 | March 30, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 2 | December 22, 2025 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | January 31, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 51 | October 28, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 17 | September 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 12 | September 30, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 4 | June 1, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 3 | September 30, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 2 | September 24, 2025 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 1 | June 26, 2026 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 1 | June 1, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 1 | January 9, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | November 14, 2025 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | August 18, 2025 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). 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](https://creativecommons.org/licenses/by/4.0/).