Data / FDA device clearances / Texas
FDA device clearances in Texas: 347 since Nov 2024
The full list. FDA device clearances for applicants in Texas: 347 rows for $17.35, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 18 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/texas, 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 347 device decisions for applicants in Texas from November 12, 2024 to October 30, 2026: 145 510(k) clearances and De Novo grants and 202 PMA approvals and supplements, for 95 applicants. The newest, P190018/S050 on October 30, 2026, is Clareon Vivity Pro Extended Vision IOLs from Alcon Laboratories, LLC.
The request: Every new FDA device clearance or approval for a company in Texas, 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.
- 347Decisions
- 145510(k) and De Novo
- 202PMA
- October 30, 2026Latest decision
Newest decisions
The newest 100 of 347, 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 30, 2026 | P190018/S050 | Clareon Vivity Pro Extended Vision IOLs | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | POE | accessdata.fda.gov |
| October 30, 2026 | P160035/S054 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | Approved | PMA 135-day supplement | DSQ | accessdata.fda.gov |
| October 30, 2026 | P140009/S144 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| October 30, 2026 | P140009/S142 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| October 30, 2026 | P010032/S266 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| October 30, 2026 | P010032/S264 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| October 28, 2026 | P160035/S061 | EXCOR Pediatric VAD | Berlin Heart, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | DSQ | accessdata.fda.gov |
| October 28, 2026 | P150004/S101 | Dorsal Root Ganglion Stimulation (DRG) EPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | PMP | accessdata.fda.gov |
| October 28, 2026 | P140009/S141 | Deep Brain Stimulation (DBS) EPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| October 28, 2026 | P010032/S262 | Spinal Cord Stimulation (SCS) External Pulse Generator (EPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| October 27, 2026 | P140009/S143 | Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| October 27, 2026 | P010032/S265 | Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| October 26, 2026 | K262276 | Cyperus | Contrario Medical, Inc. | Texas | Substantially Equivalent | 510(k) traditional | MQK | accessdata.fda.gov |
| October 23, 2026 | P160035/S060 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | DSQ | accessdata.fda.gov |
| October 23, 2026 | K260640 | Kinetic Software Library | Monebo Technologies, Inc. | Texas | Substantially Equivalent | 510(k) traditional | DPS | accessdata.fda.gov |
| October 21, 2026 | K261347 | DASH Flu A/B Test | Nuclein, LLC | Texas | Substantially Equivalent | De Novo (dual track) | OCC | accessdata.fda.gov |
| October 16, 2026 | K260168 | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) | Skycade Med Corporation | Texas | Substantially Equivalent | 510(k) traditional | DQX | accessdata.fda.gov |
| October 14, 2026 | P160035/S056 | EXCOR Pediatric VAD | Berlin Heart, Inc. | Texas | Approved | PMA 135-day supplement | DSQ | accessdata.fda.gov |
| October 14, 2026 | K261961 | Ntegrate Threaded Nail System | Nvision Biomedical Technologies | Texas | Substantially Equivalent | 510(k) traditional | HWC | accessdata.fda.gov |
| October 5, 2026 | K260005 | MyoVista wavECG (DG-200-B15-003) | HeartSciences, Inc. | Texas | Substantially Equivalent | 510(k) traditional | DPS | accessdata.fda.gov |
| October 2, 2026 | P970003/S254 | VNS Therapy® System | LivaNova USA, Inc. | Texas | Approved | PMA real-time process supplement | LYJ | accessdata.fda.gov |
| October 2, 2026 | K263086 | AltiVate Reverse® Glenosphere with RAVN Technology | Encore Medical L.P. | Texas | Substantially Equivalent | 510(k) special | PHX | accessdata.fda.gov |
| October 1, 2026 | P890047/S072 | PROVISC Ophthalmic Viscosurgical Device | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | LZP | accessdata.fda.gov |
| October 1, 2026 | P840064/S094 | VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscosurgical System; DISCOVISC Ophthalmic... | Alcon Laboratories | Texas | 30-day notice accepted | PMA 30-day notice | LZP | accessdata.fda.gov |
| October 1, 2026 | P160035/S057 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | Approved | PMA 135-day supplement | DSQ | accessdata.fda.gov |
| September 29, 2026 | DEN260007 | SmartRead(TM) Medical Device Identifier (4100) | BridgeSource Medical Corporation | Texas | Unknown | De Novo | SJJ | accessdata.fda.gov |
| September 25, 2026 | K261992 | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | Texas | Substantially Equivalent | 510(k) traditional | JOJ | accessdata.fda.gov |
| September 23, 2026 | P150004/S100 | Proclaim DRG IPG | Abbott Medical | Texas | Approved | PMA real-time process supplement | PMP | accessdata.fda.gov |
| September 23, 2026 | P140009/S139 | Infinity DBS IPG | Abbott Medical | Texas | Approved | PMA real-time process supplement | MHY | accessdata.fda.gov |
| September 23, 2026 | P010032/S260 | Proclaim family of SCS IPG | Abbott Medical | Texas | Approved | PMA real-time process supplement | LGW | accessdata.fda.gov |
| September 18, 2026 | P010032/S251 | Quattrode®; Octrode; Penta; Lamitrode; Tripole; TriCentrus Lead Extensions | Abbott Medical | Texas | Approved | PMA 135-day supplement | LGW | accessdata.fda.gov |
| September 18, 2026 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | Texas | Substantially Equivalent | 510(k) special | HRS | accessdata.fda.gov |
| September 16, 2026 | P210007/S015 | Vivistim® System | Mobia Medical, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | QPY | accessdata.fda.gov |
| September 16, 2026 | K261865 | AerFrame Alignment Laser Box (LBV2) | Stabilix, LLC | Texas | Substantially Equivalent | 510(k) traditional | IYE | accessdata.fda.gov |
| September 11, 2026 | P140009/S140 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| September 11, 2026 | P010032/S261 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| September 11, 2026 | K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETE | Bone Solutions, Inc. | Texas | Substantially Equivalent | 510(k) traditional | MQV | accessdata.fda.gov |
| September 9, 2026 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and... | Maxter Healthcare, Inc. | Texas | Substantially Equivalent | 510(k) traditional | LZA | accessdata.fda.gov |
| September 4, 2026 | K253909 | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. | Texas | Substantially Equivalent | 510(k) traditional | KIF | accessdata.fda.gov |
| September 3, 2026 | K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | Texas | Substantially Equivalent | 510(k) traditional | DXN | accessdata.fda.gov |
| September 2, 2026 | K262364 | Ellian Enigma RF Device | Ellian Corp | Texas | Substantially Equivalent | 510(k) traditional | GEI | accessdata.fda.gov |
| September 1, 2026 | P160035/S058 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | Approved | PMA 180-day supplement | DSQ | accessdata.fda.gov |
| August 26, 2026 | K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | Texas | Substantially Equivalent | 510(k) special | ODP | accessdata.fda.gov |
| August 21, 2026 | K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | Texas | Substantially Equivalent | 510(k) traditional | OVE | accessdata.fda.gov |
| August 20, 2026 | DEN250043 | Qoramatic Automated Stool Management | Cm Technologies, Inc. | Texas | Unknown | De Novo | SJB | accessdata.fda.gov |
| August 17, 2026 | P190018/S051 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System, Clareon... | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | HQL | accessdata.fda.gov |
| August 12, 2026 | P970003/S249 | VNS Therapy System | LivaNova USA, Inc. | Texas | Approved | PMA 180-day supplement | LYJ | accessdata.fda.gov |
| August 12, 2026 | K260944 | ManaCold Compression System | Manamed, LLC | Texas | Substantially Equivalent | 510(k) traditional | IRP | accessdata.fda.gov |
| August 11, 2026 | K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | Texas | Substantially Equivalent | 510(k) traditional | FRO | accessdata.fda.gov |
| August 7, 2026 | P140009/S133 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | Approved | PMA real-time process supplement | MHY | accessdata.fda.gov |
| August 7, 2026 | P010032/S254 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | Approved | PMA real-time process supplement | LGW | accessdata.fda.gov |
| August 5, 2026 | P160035/S059 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | DSQ | accessdata.fda.gov |
| August 4, 2026 | P890047/S070 | PROVISC Ophthalmic Viscosurgical Device | Alcon Research, Ltd. | Texas | Approved | PMA 180-day supplement | LZP | accessdata.fda.gov |
| August 4, 2026 | P840064/S092 | VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System. | Alcon Laboratories | Texas | Approved | PMA 180-day supplement | LZP | accessdata.fda.gov |
| July 31, 2026 | K261912 | SnØreNegatØr | DnB Innovations, LLC | Texas | Substantially Equivalent | 510(k) traditional | LRK | accessdata.fda.gov |
| July 31, 2026 | K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | Texas | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| July 30, 2026 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | Texas | Substantially Equivalent | 510(k) traditional | CCL | accessdata.fda.gov |
| July 26, 2026 | P150004/S099 | Dorsal Root Ganglion (DRG) IPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | PMP | accessdata.fda.gov |
| July 26, 2026 | P140009/S138 | Deep Brain Stimulation (DBS) IPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| July 26, 2026 | P010032/S259 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| July 22, 2026 | K262094 | E3D-C Interbody System | Evolution Spine | Texas | Substantially Equivalent | 510(k) special | OVE | accessdata.fda.gov |
| July 17, 2026 | P140009/S134 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| July 17, 2026 | P010032/S255 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| July 9, 2026 | K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | Texas | Substantially Equivalent | 510(k) traditional | DQK | accessdata.fda.gov |
| July 8, 2026 | P930014/S164 | AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | HQL | accessdata.fda.gov |
| July 8, 2026 | K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | Texas | Substantially Equivalent | 510(k) special | ODP | accessdata.fda.gov |
| July 8, 2026 | K253751 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | Texas | Substantially Equivalent | 510(k) traditional | QFM | accessdata.fda.gov |
| July 6, 2026 | P930014/S163 | Acrosof Posterior Chamber Intraocular Lens | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | HQL | accessdata.fda.gov |
| July 6, 2026 | P190018/S053 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic... | Alcon Laboratories, LLC | Texas | 30-day notice accepted | PMA 30-day notice | HQL | accessdata.fda.gov |
| July 6, 2026 | P040020/S120 | AcrySof ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | MFK | accessdata.fda.gov |
| July 6, 2026 | K261909 | Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. | Texas | Substantially Equivalent | 510(k) traditional | NUC | accessdata.fda.gov |
| July 2, 2026 | P930014/S165 | AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | HQL | accessdata.fda.gov |
| July 2, 2026 | P190018/S054 | Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic... | Alcon Laboratories, LLC | Texas | 30-day notice accepted | PMA 30-day notice | HQL | accessdata.fda.gov |
| July 2, 2026 | P190018/S052 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic... | Alcon Laboratories, LLC | Texas | 30-day notice accepted | PMA 30-day notice | HQL | accessdata.fda.gov |
| July 2, 2026 | P140009/S132 | Liberta RC Deep Brain Stimulation (DBS) IPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
| July 2, 2026 | P040020/S121 | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | MFK | accessdata.fda.gov |
| July 2, 2026 | P040020/S119 | AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL | Alcon Research, Ltd. | Texas | 30-day notice accepted | PMA 30-day notice | MFK | accessdata.fda.gov |
| July 2, 2026 | P010032/S253 | Etema Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| June 30, 2026 | P150004/S095 | Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | Approved | PMA real-time process supplement | PMP | accessdata.fda.gov |
| June 24, 2026 | K253404 | CLEAR Aspiration System | Insera Therapeutics, Inc. | Texas | Substantially Equivalent | 510(k) traditional | accessdata.fda.gov | |
| June 18, 2026 | P250013/S002 | aura6000 system | LivaNova USA, Inc. | Texas | Approved | PMA 180-day supplement | MNQ | accessdata.fda.gov |
| June 18, 2026 | P210007/S014 | Vivistim Pair VNS System | Mobia Medical, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | QPY | accessdata.fda.gov |
| June 18, 2026 | K253050 | RadOncAI | Informai | Texas | Substantially Equivalent | 510(k) traditional | MUJ | accessdata.fda.gov |
| June 12, 2026 | K261366 | Virtus | Somnomed, Inc. | Texas | Substantially Equivalent | 510(k) special | LRK | accessdata.fda.gov |
| June 11, 2026 | K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield... | FloShield, Inc. | Texas | Substantially Equivalent | 510(k) traditional | GCJ | accessdata.fda.gov |
| June 4, 2026 | P170034/S018 | Hydrus® Microstent | Alcon Research, LLC | Texas | 30-day notice accepted | PMA 30-day notice | OGO | accessdata.fda.gov |
| June 4, 2026 | K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | Texas | Substantially Equivalent | 510(k) traditional | GCJ | accessdata.fda.gov |
| May 29, 2026 | P010019/S087 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | Alcon Laboratories, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | LPM | accessdata.fda.gov |
| May 26, 2026 | P010032/S252 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | accessdata.fda.gov |
| May 21, 2026 | DEN250028 | DeepView AI® System | Spectralmd, Inc. | Texas | Unknown | De Novo | SHY | accessdata.fda.gov |
| May 15, 2026 | P260004 | Signatera CDx | Natera, Inc. | Texas | Approved | PMA original approval | PQP | accessdata.fda.gov |
| May 15, 2026 | P190018/S046 | Clareon Vivity Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL) | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | HQL | accessdata.fda.gov |
| May 8, 2026 | K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | Texas | Substantially Equivalent | 510(k) traditional | IYE | accessdata.fda.gov |
| May 4, 2026 | K252954 | MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | Texas | Substantially Equivalent | 510(k) traditional | QFM | accessdata.fda.gov |
| May 1, 2026 | K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | Texas | Substantially Equivalent | 510(k) traditional | PKC | accessdata.fda.gov |
| April 30, 2026 | P930014/S161 | AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL... | Alcon Laboratories, Inc. | Texas | Approved | PMA 180-day supplement | HQL | accessdata.fda.gov |
| April 30, 2026 | P250013/S001 | aura6000 system | LivaNova USA, Inc. | Texas | Approved | PMA 180-day supplement | MNQ | accessdata.fda.gov |
| April 30, 2026 | P190018/S048 | Clareon Aspheric Hydrophobic Acrylic IOL (SY60WF); Clareon Aspheric UV Absorbing IOL (CC60WF); Clareon Toric... | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | HQL | accessdata.fda.gov |
| April 30, 2026 | P150004/S094 | Proclaim Dorsal Root Ganglion (DRG) IPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | PMP | accessdata.fda.gov |
| April 30, 2026 | P140009/S131 | Infinity Deep Brain Stimulation (DBS) IPG; Liberta RC DBS IPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| Abbott Medical | 99 | October 30, 2026 |
| Alcon Laboratories, Inc. | 25 | July 8, 2026 |
| Alcon Laboratories, LLC | 16 | October 30, 2026 |
| Berlin Heart, Inc. | 15 | October 30, 2026 |
| Alcon Research, Ltd. | 15 | October 1, 2026 |
| LivaNova USA, Inc. | 13 | October 2, 2026 |
| Mobia Medical, Inc. | 11 | September 16, 2026 |
| Encore Medical L.P. | 9 | October 2, 2026 |
| Healgen Scientific,, LLC | 7 | April 13, 2026 |
| Alcon Laboratories | 6 | October 1, 2026 |
| Alcon Research, LLC | 5 | June 4, 2026 |
| Nvision Biomedical Technologies, Inc. | 5 | April 1, 2026 |
| Phasor Health, LLC | 5 | November 21, 2025 |
| Nvision Biomedical Technologies | 4 | October 14, 2026 |
| Argon Medical Devices, Inc. | 4 | February 23, 2026 |
| Neurocareai, Inc. (Dba Savelife.Ai) | 3 | July 31, 2026 |
| Evolution Spine | 3 | July 22, 2026 |
| Medcad | 3 | March 27, 2026 |
| Astura Medical | 3 | January 22, 2026 |
| Acuity Surgical Devices, LLC | 3 | July 30, 2025 |
By panel
| Panel | Decisions | Latest |
|---|---|---|
| Neurology | 122 | October 30, 2026 |
| Ophthalmic | 67 | October 30, 2026 |
| Orthopedic | 54 | October 14, 2026 |
| Cardiovascular | 26 | October 30, 2026 |
| Radiology | 13 | September 16, 2026 |
| Physical Medicine | 12 | September 16, 2026 |
| General, Plastic Surgery | 10 | September 2, 2026 |
| Gastroenterology, Urology | 8 | August 20, 2026 |
| Dental | 7 | September 4, 2026 |
| Anesthesiology | 5 | July 30, 2026 |
| Clinical Toxicology | 5 | March 16, 2026 |
| Obstetrics/Gynecology | 4 | October 26, 2026 |
| General Hospital | 4 | September 25, 2026 |
| Microbiology | 3 | October 21, 2026 |
| Unknown | 3 | August 11, 2026 |
| Ear, Nose, Throat | 2 | April 26, 2026 |
| Pathology | 1 | May 15, 2026 |
| Clinical Chemistry | 1 | December 23, 2025 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| PMA 30-day notice | 116 | October 30, 2026 |
| 510(k) traditional | 114 | October 26, 2026 |
| PMA real-time process supplement | 39 | October 2, 2026 |
| PMA 180-day supplement | 35 | October 30, 2026 |
| 510(k) special | 23 | October 2, 2026 |
| PMA 135-day supplement | 5 | October 30, 2026 |
| De Novo | 5 | September 29, 2026 |
| PMA special supplement | 4 | April 25, 2026 |
| De Novo (dual track) | 2 | October 21, 2026 |
| PMA original approval | 2 | May 15, 2026 |
| 510(k) abbreviated | 1 | November 6, 2025 |
| PMA panel track supplement | 1 | March 5, 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.