Continuously-updated intelligence on 510(k) clearances, sponsors, product codes, and device classifications — sourced directly from openFDA.
Click a sponsor name for their full portfolio, product codes, and clearance history. Browse all sponsors →
| Sponsor | Total | Last 12 mo | Codes | Classes | Most recent |
|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 156 | 13 | 16 | 2 | 2026-06-25 |
| Boston Scientific | 120 | 19 | 46 | 2 | 2026-08-12 |
| Arthrex, Inc. | 117 | 19 | 25 | 2 / U | 2026-08-07 |
| Medacta International S.A. | 100 | 11 | 32 | 2 | 2026-05-05 |
| STERIS Corporation | 79 | 5 | 25 | 2 | 2026-06-24 |
| Intuitive Surgical, Inc. | 76 | 18 | 7 | 2 | 2026-08-07 |
| Smith & Nephew | 74 | 5 | 27 | 2 | 2026-07-09 |
| Olympus Medical Systems Corporation | 73 | 23 | 31 | 2 / U | 2026-07-31 |
| Stryker GmbH | 72 | 3 | 33 | U / 2 | 2026-06-29 |
| Canon Medical Systems Corporation | 72 | 9 | 8 | 2 | 2026-05-20 |
| Medtronic, Inc. | 71 | 10 | 36 | 2 | 2026-07-31 |
| Becton, Dickinson and Company | 63 | 8 | 25 | 1 / 2 | 2026-04-15 |
| Varian Medical Systems | 63 | 11 | 9 | 2 | 2026-08-03 |
| Shanghai United Imaging Healthcare Co., Ltd. | 61 | 11 | 9 | 2 | 2026-07-28 |
| Covidien, LLC | 60 | 8 | 25 | 2 / U | 2026-07-01 |
| Beckman Coulter, Inc. | 59 | 7 | 39 | 2 | 2026-03-24 |
| ABBOTT MEDICAL | 55 | 13 | 19 | 2 | 2026-07-15 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 53 | 11 | 8 | 2 | 2026-06-25 |
| Dentsply Sirona | 52 | 10 | 19 | 1 / 2 | 2026-04-23 |
| Edwards Lifesciences, LLC | 50 | 10 | 18 | 2 | 2026-06-26 |
Click a product code for its definition, regulation, and sponsor landscape. Browse all product codes →
| Code | Device name | Class | Specialty | Total | 12mo | Sponsors |
|---|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 471 | 53 | 309 |
| LZA | — | — | — | 440 | 12 | 272 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 420 | 73 | 194 |
| FXX | — | — | — | 384 | 9 | 333 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 371 | 54 | 178 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | 343 | 57 | 79 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 323 | 53 | 112 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 318 | 93 | 178 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 268 | 52 | 108 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 263 | 22 | 114 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | 254 | 36 | 85 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 242 | 31 | 128 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 227 | 22 | 114 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 197 | 31 | 55 |
| LNH | — | — | — | 187 | 24 | 61 |
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | 176 | 23 | 56 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | 176 | 29 | 89 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology, Urology | 169 | 31 | 97 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 150 | 20 | 82 |
| ITI | Wheelchair, Powered | Class II | Physical Medicine | 135 | 34 | 82 |
| Code | Device name | Class | Specialty | Last yr | Prior yr | Growth |
|---|---|---|---|---|---|---|
| LRK | Device, Anti-Snoring | Class II | Dental | 19 | 3 | +533.3% |
| IOR | Wheelchair, Mechanical | Class I | Physical Medicine | 17 | 4 | +325.0% |
| — | — | — | — | 11 | 3 | +266.7% |
| MHX | — | — | — | 14 | 4 | +250.0% |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 24 | 7 | +242.9% |
| EMA | Cement, Dental | Class II | Dental | 12 | 4 | +200.0% |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | Class II | General, Plastic Surgery | 9 | 3 | +200.0% |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 20 | 7 | +185.7% |
| IYE | — | — | — | 17 | 6 | +183.3% |
| HCG | — | — | — | 7 | 3 | +133.3% |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | Class II | Clinical Chemistry | 7 | 3 | +133.3% |
| NEW | — | — | — | 7 | 3 | +133.3% |
| QEZ | Aspiration Thrombectomy Catheter | Class II | Cardiovascular | 7 | 3 | +133.3% |
| DQD | Stethoscope, Electronic | Class II | Cardiovascular | 7 | 3 | +133.3% |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | 7 | 3 | +133.3% |
Recent PMA decisions. PMA covers the highest-risk (Class III) devices — full safety + effectiveness review.
| Date | PMA # | Sponsor | Trade name | Type | Code | Specialty |
|---|---|---|---|---|---|---|
| 2026-08-14 | P970004-S456 | Medtronic Neuromodulation | InterStim Therapy System, Verify Evaluation System | 30-Day Notice | EZW | — |
| 2026-08-14 | P960009-S541 | Medtronic, Inc. | Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense | 30-Day Notice | MHY | Unknown |
| 2026-08-14 | P910001-S126 | Spectranetics Corp. | ELCA Coronary Laser Atherectomy Catheters | 135 Review Track For 30-Day Notice | LPC | Unknown |
| 2026-08-14 | P840001-S631 | Medtronic Neuromodulation | Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Spe | 30-Day Notice | LGW | — |
| 2026-08-14 | P240011-S015 | Medtronic Neuromodulation | Altaviva | 30-Day Notice | QPT | Unknown |
| 2026-08-14 | P230011-S006 | Illumina, Inc. | TruSight Oncology Comprehensive | Panel Track | PQP | — |
| 2026-08-14 | P160043-S095 | Medtronic Vascular | Resolute Onyx Zotarolimus-Eluting Coronary Stent System | 30-Day Notice | NIQ | Unknown |
| 2026-08-14 | P160037-S028 | Becton, Dickinson and Company | BD Onclarity HPV Assay | Real-Time Process | MAQ | Unknown |
| 2026-08-14 | P080025-S350 | Medtronic Neuromodulation | InterStim Therapy System, Verify Evaluation System | 30-Day Notice | QON | — |
| 2026-08-13 | P860004-S460 | Medtronic, Inc. | SynchroMed Infusion System, Ascenda Intrathecal Catheters | 30-Day Notice | LKK | Unknown |
| 2026-08-13 | P230040-S032 | Endotronix, Inc. | Cordella Pulmonary Artery Sensor System (CorPASS) | 30-Day Notice | MOM | Unknown |
| 2026-08-13 | P220023-S011 | Recor Medical, Inc. | Paradise Ultrasound Renal Denervation System (Paradise System) | Normal 180 Day Track No User Fee | QYI | Unknown |
| 2026-08-13 | P000006-S076 | Coloplast Corp. | Titan Inflatable Penile Prosthesis | 30-Day Notice | FHW | Gastroenterology, Urology |
| 2026-08-12 | P970003-S249 | LivaNova USA, Inc. | VNS Therapy System | Normal 180 Day Track | LYJ | Unknown |
| 2026-08-12 | P910023-S487 | ABBOTT MEDICAL | Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA600T, | 30-Day Notice | LWS | Unknown |
Recent enforcement actions. Open Recalls Explorer →
| Date | Severity | Recalling firm | Product | Code | Status |
|---|---|---|---|---|---|
| 2026-07-17 | Class II | Remel Europe Ltd. | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diag… | — | Ongoing |
| 2026-07-16 | Class II | Straumann USA LLC | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5… | — | Ongoing |
| 2026-07-16 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236,… | — | Ongoing |
| 2026-07-16 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722… | — | Ongoing |
| 2026-07-16 | Class II | Biofire Defense | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGD… | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2)… | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) … | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) C… | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) P… | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT… | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC | — | Ongoing |
| 2026-07-14 | Class II | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRA… | — | Ongoing |
| 2026-07-13 | Class II | OBP Medical Corporation | OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1 | — | Ongoing |
| 2026-07-13 | Class II | Straumann USA LLC | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 | — | Ongoing |
| Date | K-number | Sponsor | Device | Code | Class |
|---|---|---|---|---|---|
| 2026-08-16 | K260563 | FIND Surgical Sciences Inc. D/B/A FIND Neuro | CN-Suite | OLX | Class II |
| 2026-08-14 | K262639 | Spineart SA | BAGUERA® C Cervical Disc Surgical Instruments | QLQ | Class II |
| 2026-08-14 | K262571 | Bard Peripheral Vascular, Inc. | EnCor EnCompass Breast Biopsy and Tissue Removal System | KNW | Class II |
| 2026-08-14 | K262552 | Scivita Medical Technology Co., Ltd. | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | FGB | — |
| 2026-08-14 | K262452 | Radformation, Inc. | AutoContour (RADAC V6) | QKB | Class II |
| 2026-08-14 | K262449 | ADVAHEALTH SOLUTIONS, LLC | AdvaView | LLZ | Class II |
| 2026-08-14 | K262424 | Arbor Endovascular, LLC | Willow 12 Guidewire | MOF | — |
| 2026-08-14 | K262419 | Cerenovus, Inc. | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | HCG | — |
| 2026-08-14 | K261890 | Boehringer Laboratories, LLC | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | KNT | Class II |
| 2026-08-14 | K261646 | Beijing Kreate Medical Co., Ltd. | Redermax® Antibacterial Wound Matrix | FRO | Unclassified |
| 2026-08-14 | K261428 | Medtronic Ireland | NC Euphora Rapid Exchange Balloon Dilatation Catheter | LOX | — |
| 2026-08-14 | K261228 | Brain Ultimate, Inc. | QuickVision Ultimate rTMS | OBP | Class II |
| 2026-08-14 | K260898 | Screenpoint Medical B.V. | Transpara (2.1.0) | QDQ | Class II |
| 2026-08-14 | K260559 | IMDS Operation B.V. | NHanceIT | DQY | — |
| 2026-08-14 | K260438 | Infinium Medical, Inc. | Vital Signs Monitor (CLEO2) | MWI | — |
| 2026-08-14 | K260374 | Empatica S.r.l. | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | GYD | Class II |
| 2026-08-14 | K260171 | BMC Medical Co., Ltd. | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | CAW | — |
| 2026-08-14 | K253747 | Jiangsu Enjosim Medical Technology Co., Ltd. | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | FMF | — |
| 2026-08-14 | K253562 | Schiller AG | medilogFD | MWJ | Class II |
| 2026-08-13 | K262398 | CERENOVUS, Inc. | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | NRY | Class II |
| 2026-08-13 | K261626 | Guangzhou Heygears IMC., Inc. | UltraPrint Flexible Denture UV | EBI | — |
| 2026-08-13 | K261499 | Aw Technologies Aps | TrachFlush | BSK | Class II |
| 2026-08-13 | K261139 | Freyja Healthcare, LLC | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | GCJ | Class II |
| 2026-08-13 | K261061 | Wellvii, Inc. | BP Go (BPP-855) | DXN | Class II |
| 2026-08-13 | K260907 | Covidien LP | BIS Advance pEEG Module | OLW | Class II |
Warehouse data is a lagging indicator — clearances reflect ~12–18 months of prior R&D and regulatory work. These sources carry the leading edge; each goes live here as its feed comes online.
| Date | Signal | Firm |
|---|---|---|
| 2026-08-28 |
Philips Korea and HoneyNaps Sign Strategic MOU to Advance Sleep and Cardiovascular Health
Partnership will explore new healthcare opportunities arising from the link between sleep disorders and cardiovascular disease Collaboration to span the integration of sleep data with cardiovascular risk factors, academic initiatives, and more Philips' health technology expertise |
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| 2026-08-28 |
Invitation to presentation of Sectra's three-month report 2026/2027
LINKÖPING, Sweden, Aug. 28, 2026 /PRNewswire/ -- International medical imaging IT and cybersecurity company Sectra (STO: SECT B) invites investors, analysts, and the media to a presentation of the company's three-month report with President Torbjörn Kronander and CFO Jessica Holm |
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| 2026-08-28 |
Leo Cancer Care Announces Commercial Collaboration with Leading Healthcare Solutions Provider to Bring Connected Imaging and Radiation Therapy Workflows to Market
MIDDLETON, Wis., Aug. 28, 2026 /PRNewswire/ -- Leo Cancer Care, a pioneer in upright radiation therapy, today announced a commercial collaboration with GE HealthCare, a leading healthcare solutions provider. Under the agreement, the two companies intend to work together on GE Hea |
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| 2026-08-28 |
Singclean 2nd Leaders Summit Charts New Course in Global Aesthetics
SHANGHAI, Aug. 28, 2026 /PRNewswire/ -- Hosted within the IMCAS China Conference venue at W Shanghai - The Bund, Singclean 2nd International Medical Aesthetic Leaders Summit themed "Global Vision, Embark on a New Chapter" came to a successful conclusion. Gathering top global doct |
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| 2026-08-27 |
ROBERT H. GREGG II, DDS, HONORED BY CITY OF CERRITOS FOR BUSINESS LEADERSHIP AND COMMUNITY IMPACT
City Proclamation Recognizes Contributions to Patient Care, Dental Innovation, Clinician Education and Community Service CERRITOS, Calif., Aug. 27, 2026 /PRNewswire/ -- Robert H. Gregg II, DDS, Founder, President and Chairman of the Board of Millennium Dental Technologies, Inc. a |
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| 2026-08-27 |
China's 1st Full-stack MRI-Based BCI Solution Released in Tianjin
TIANJIN, China, Aug. 27, 2026 /PRNewswire/ -- China's first National Conference on MRI-Based Brain-Computer Interfaces (BCIs) was held in Tianjin on August 23, 2026, bringing together about 400 experts and representatives from academia, hospitals, leading companies and regulatory |
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| 2026-08-27 |
NYU Langone Health Names Sunil Rao, MD, Director of the Leon H. Charney Division of Cardiology and Welcomes Susheel Kodali, MD, to Lead Interventional Cardiology
NEW YORK, Aug. 27, 2026 /PRNewswire/ -- NYU Langone Health has appointed Sunil Rao, MD, an internationally recognized clinician-investigator whose work has introduced new approaches to treating patients with complex cardiovascular conditions, as director of the Leon H. Charney Di |
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| 2026-08-27 |
Společnost Biosidus rozšiřuje výrobní kapacitu biologických léčiv a posiluje globální dodavatelské kapacity pro agalsidázu beta
BUENOS AIRES, Argentina, 27. srpna 2026 /PRNewswire/ -- Argentinská biotechnologická společnost Biosidus, která má více než čtyřicetileté zkušenosti s vývojem a výrobou biosimilárních léčivých přípravků, oznámila, že její nový závod s bioreaktory byl uveden do provozu. Společnost |
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New trial starts and registry updates — a strong leading indicator for where R&D money is being spent.
MD&M, RSNA, AAOS, AAOMS, ADA, ASCO, HIMSS, CES Health. Next-30-days view of firms exhibiting and what they're launching — real-time signal of where the booth budget is going.
MedTech Dive, MassDevice, MedCity News, MD+DI editorial + SEC 8-K M&A filings. Concurrent and retrospective context.
| Date | Signal | Firm |
|---|---|---|
| 2026-07-26 |
AI device authorizations: what the FDA record shows
FDA authorizations for AI-enabled imaging software grew twentyfold from 2018 to 2025 — then flattened in 2026. Every count queried from openFDA, query… |
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| 2026-07-26 |
What a 510(k) clearance does not guarantee a buyer
A 510(k) clearance makes an AI device legal to sell — not clinically superior or commercially proven. The four gaps category buyers have to close themselves. |
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| 2026-07-26 |
FDA cleared vs approved vs granted vs registered
Cleared, approved, granted, and registered mean very different things at the FDA. What each proves about an AI tool, and how to verify any claim yourself. |
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| 2026-07-25 |
Introducing Insights
Welcome to Insights, the new analysis section of Elephant Hawk. Each week we publish a short, data-driven read on the medtech regulatory landscape — built… |
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