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. | 159 | 16 | 16 | 2 | 2026-09-25 |
| Boston Scientific Corporation | 125 | 21 | 46 | 2 | 2026-09-11 |
| Arthrex, Inc. | 120 | 21 | 25 | 2 / U | 2026-09-25 |
| Medacta International S.A. | 102 | 10 | 32 | 2 | 2026-09-17 |
| STERIS Corporation | 79 | 4 | 25 | 2 | 2026-06-24 |
| Intuitive Surgical, Inc. | 77 | 12 | 7 | 2 | 2026-09-08 |
| Olympus Medical Systems Corporation | 77 | 20 | 32 | U / 2 | 2026-09-10 |
| Smith & Nephew, Inc. | 75 | 5 | 27 | 2 | 2026-09-08 |
| Medtronic, Inc. | 74 | 13 | 37 | 2 | 2026-09-17 |
| Canon Medical Systems Corporation | 72 | 8 | 8 | 2 | 2026-05-20 |
| Stryker GmbH | 72 | 3 | 33 | 2 / U | 2026-06-29 |
| Becton, Dickinson and Company | 64 | 8 | 26 | 1 / 2 | 2026-09-14 |
| Varian Medical Systems, Inc. | 63 | 10 | 9 | 2 | 2026-08-03 |
| Shanghai United Imaging Healthcare Co., Ltd. | 62 | 8 | 9 | 2 | 2026-08-21 |
| Covidien | 61 | 7 | 25 | U / 2 | 2026-09-15 |
| Beckman Coulter, Inc. | 60 | 6 | 39 | 2 / 1 | 2026-09-21 |
| ABBOTT MEDICAL | 56 | 11 | 19 | 2 | 2026-09-17 |
| Dentsply Sirona | 54 | 11 | 19 | 1 / 2 | 2026-09-04 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 53 | 8 | 8 | 2 | 2026-06-25 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics | 51 | 11 | 4 | 2 | 2026-09-16 |
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 | 478 | 52 | 314 |
| LZA | Polymer Patient Examination Glove | Class I | General Hospital | 445 | 17 | 274 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 434 | 77 | 196 |
| FXX | Mask, Surgical | Class II | General, Plastic Surgery | 384 | 8 | 333 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 378 | 52 | 180 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Class II | Radiology | 347 | 56 | 79 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 332 | 93 | 186 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 329 | 58 | 115 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 269 | 49 | 108 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 264 | 21 | 114 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | 256 | 36 | 87 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 247 | 35 | 132 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 229 | 21 | 114 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 201 | 34 | 55 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Class II | Radiology | 192 | 25 | 62 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | 180 | 31 | 90 |
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | 179 | 21 | 57 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology, Urology | 172 | 31 | 98 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 155 | 23 | 84 |
| ITI | Wheelchair, Powered | Class II | Physical Medicine | 140 | 36 | 85 |
| Code | Device name | Class | Specialty | Last yr | Prior yr | Growth |
|---|---|---|---|---|---|---|
| — | — | — | — | 13 | 3 | +333.3% |
| IOR | Wheelchair, Mechanical | Class I | Physical Medicine | 21 | 5 | +320.0% |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | 16 | 5 | +220.0% |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 25 | 8 | +212.5% |
| QJI | Interoperable Automated Glycemic Controller | Class II | Clinical Chemistry | 9 | 3 | +200.0% |
| LRK | Device, Anti-Snoring | Class II | Dental | 16 | 6 | +166.7% |
| QEZ | Aspiration Thrombectomy Catheter | Class II | Cardiovascular | 8 | 3 | +166.7% |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | Class II | General, Plastic Surgery | 8 | 3 | +166.7% |
| FYA | Gown, Surgical | Class II | General, Plastic Surgery | 10 | 4 | +150.0% |
| MOF | Guide, Wire, Catheter, Neurovasculature | Class II | Cardiovascular | 12 | 5 | +140.0% |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | 7 | 3 | +133.3% |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General, Plastic Surgery | 7 | 3 | +133.3% |
| IYE | Accelerator, Linear, Medical | Class II | Radiology | 18 | 8 | +125.0% |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 18 | 9 | +100.0% |
| EHD | Unit, X-Ray, Extraoral With Timer | Class II | Dental | 6 | 3 | +100.0% |
Recent PMA decisions. PMA covers the highest-risk (Class III) devices — full safety + effectiveness review.
| Date | PMA # | Sponsor | Trade name | Type | Code | Specialty |
|---|---|---|---|---|---|---|
| 2026-09-25 | P980023-S151 | Biotronik, Inc. | Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva | 30-Day Notice | LWS | Unknown |
| 2026-09-25 | P980023-S140 | Biotronik, Inc. | Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 | Normal 180 Day Track | LWS | Unknown |
| 2026-09-25 | P980016-S965 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD | 30-Day Notice | LWS | Unknown |
| 2026-09-25 | P950037-S279 | Biotronik, Inc. | Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- | Normal 180 Day Track | DXY | Cardiovascular |
| 2026-09-25 | P830055-S375 | Depuy, Inc. | LCS® Total Knee System | 30-Day Notice | NJL | Unknown |
| 2026-09-25 | P250050 | Bard Peripheral Vascular, Inc. | Liverty TIPS Stent Graft | Original | MIR | Unknown |
| 2026-09-25 | P240038-S003 | Beaver Visitec International, Inc. | FINEVISION HP Trifocal IOLs | Real-Time Process | HQL | Ophthalmic |
| 2026-09-25 | P240012-S008 | Lungpacer Medical USA, Inc. | AeroPace® System | Real-Time Process | SDL | Unknown |
| 2026-09-25 | P230040-S033 | Endotronix, Inc. | Cordella Pulmonary Artery Sensor System (CorPASS) | 30-Day Notice | MOM | Unknown |
| 2026-09-25 | P230005-S005 | Motiva USA, LLC | Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants | 135 Review Track For 30-Day Notice | FTR | General, Plastic Surgery |
| 2026-09-25 | P100010-S154 | Medtronic Cryocath, LP | STOP Persistent AF | Normal 180 Day Track No User Fee | OAE | Unknown |
| 2026-09-25 | P070008-S172 | Biotronik, Inc. | Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H | Normal 180 Day Track | NKE | Unknown |
| 2026-09-25 | P050023-S214 | Biotronik, Inc. | Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, Rivacor Sky HF-T QP, Riva | 30-Day Notice | MRM | Unknown |
| 2026-09-25 | P050023-S204 | Biotronik, Inc. | Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I | Normal 180 Day Track | MRM | Unknown |
| 2026-09-25 | P010031-S932 | Medtronic Cardiac Rhythm Disease Management | Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D | 30-Day Notice | NIK | Unknown |
Recent enforcement actions. Open Recalls Explorer →
| Date | Severity | Recalling firm | Product | Code | Status |
|---|---|---|---|---|---|
| 2026-08-24 | Class I | Boston Scientific Corporation | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/… | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, … | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade); | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | MR 5300 Model Number (REF): 1. 782110, 2. 782152; | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nov… | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137… | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(… | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 78… | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1… | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148… | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; | — | Ongoing |
| 2026-08-21 | Class II | Philips North America Llc | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 7811… | — | Ongoing |
| 2026-08-21 | Class II | Midmark Corporation | Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressur… | — | Ongoing |
| 2026-08-21 | Class II | Midmark Corporation | Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressur… | — | Ongoing |
| Date | K-number | Sponsor | Device | Code | Class |
|---|---|---|---|---|---|
| 2026-09-27 | K260945 | Fit-Pro KFT (Ltd.) - DBA E-Fit | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) | — | — |
| 2026-09-27 | K252139 | Rivarp Medical Pvt., Ltd. | Kentrospine Viktr-MIS® Pedicle screw system | NKB | Class II |
| 2026-09-25 | K263182 | Samsung Medison Co., Ltd. | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System | IYN | Class II |
| 2026-09-25 | K262983 | Spident Co., Ltd. | EsTemp Implant | EMA | Class II |
| 2026-09-25 | K262975 | Arthrex, Inc. | Arthrex Beaming System | HWC | Class II |
| 2026-09-25 | K262548 | Philips Ultrasound, LLC | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Class II |
| 2026-09-25 | K262215 | CMT Health PTE., Ltd. | Profoject Safety Sliding Blood Collection Set | JKA | Class II |
| 2026-09-25 | K262196 | Align Technology, Inc. | Invisalign System | PNN | Class II |
| 2026-09-25 | K261992 | Solventum US, LLC | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | JOJ | Class II |
| 2026-09-25 | K261977 | Cyden Limited | Braun Aura 9 (6042) | OHT | Class II |
| 2026-09-25 | K261372 | CMT Health PTE., Ltd. | Profoject LOR Syringe | CAZ | Class II |
| 2026-09-25 | K261336 | Cepheid | Xpert Respiratory Panel | QOF | Class II |
| 2026-09-25 | K261262 | Respironics, Inc. | Altis Full Face Mask | BZD | Class II |
| 2026-09-25 | K260140 | Aevice Health Pte. , Ltd. | Aevice Wheeze Detection Module | PHZ | Class II |
| 2026-09-25 | K260055 | Siemens Medical Solutions USA, Inc. | syngo.CT Brain Quantification | QIH | Class II |
| 2026-09-25 | K260023 | SimBioSys, Inc. | TumorSight Risk | SHW | Class II |
| 2026-09-25 | K254297 | Tempus AI, Inc. | Tempus ECG-MR | SBQ | Class II |
| 2026-09-25 | K254291 | Ezisurg Medical Co., Ltd. | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges | GDW | Class II |
| 2026-09-25 | K254255 | Wellysis Corp. | S-Patch CardioAI | DPS | Class II |
| 2026-09-25 | K254252 | Karl Storz SE & CO. KG | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | HIH | Class II |
| 2026-09-25 | K254230 | CapsoVision, Inc. | CapsoView (CVV); CapsoCloud (CLD) | QZF | Class II |
| 2026-09-25 | K254210 | Hyundai Bioland Co., Ltd. | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | NPM | Class II |
| 2026-09-25 | K254058 | Life Detection Technologies | DistaSense(TM) (v1) | DRT | Class II |
| 2026-09-24 | K263010 | inomed Medizintechnik GmbH | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | GWF | Class II |
| 2026-09-24 | K262955 | Zimmer, Inc. | OsseoFit Stemless Shoulder System | PKC | 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 |
|---|---|---|
| 2026-10-08 |
ZEISS acquires Ceres Holographics to accelerate holography industrialization
Combining decades-long holography expertise with complementary holographic innovations JENA, Germany, Oct. 8, 2026 /PRNewswire/ -- ZEISS has announced the acquisition of Ceres Holographics, a pioneering holographic technology company headquartered in Livingston, Scotland. Ceres.. |
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| 2026-10-08 |
SIBIONICS y PharmaSens exploran nuevos horizontes en la administración automatizada de insulina en la EASD 2026
MILÁN, 8 de octubre de 2026 /PRNewswire/ -- En la reunión de 2026 de la Asociación Europea para el Estudio de la Diabetes (EASD), SiBionics presentó «See More, Act Earlier» (Ver más, actuar antes), que vincula el monitoreo continuo con el futuro del cuidado de la diabetes. Esta v |
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| 2026-10-08 |
Regulated information – inside information: Fagron delivers strong 23.2% revenue growth in the third quarter to €281.3 million and confirms FY guidance range
Regulated information – inside information Nazareth-De Pinte (Belgium)/Rotterdam (The Netherlands), 8 October 2026 – 7:00 AM CET |
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| 2026-10-08 |
Gereglementeerde informatie - Voorwetenschap: Fagron realiseert in het derde kwartaal een sterke omzetgroei van 23,2% tot €281,3 miljoen en bevestigt de bandbreedte van haar vooruitzichten voor FY 2026
Gereglementeerde informatie - Voorwetenschap Nazareth-De Pinte (België)/Rotterdam (Nederland), 8 oktober 2026 – 7.00 uur CET |
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| 2026-10-07 |
Boston Scientific appoints Joseph M. Fitzgerald Executive Vice President and Chief Operating Officer
New operating structure designed to increase efficiency and support continued growth MARLBOROUGH, Mass., Oct. 7, 2026 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the appointment of Joseph M. Fitzgerald to executive vice president and chief operating |
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| 2026-10-07 |
InflammaSense Named Performer on ARPA-H's up to $38 Million CIRCLE Award to Advance Real-Time Immune Monitoring in Critical Care
Company will measure autonomic and inflammatory signatures in up to 200 critically ill patients using its VITALx-patch wearable sensor and ARC cascade-endotyping classifier LA JOLLA, Calif., Oct. 7, 2026 /PRNewswire/ -- InflammaSense, Inc., a pre-revenue medtech company developin |
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| 2026-10-07 |
MintNeuro raises $5 million to scale purpose-built chip platform for neural devices and brain-computer interfaces
Funding from European and US investors will accelerate product launch, partner adoption and international expansion LONDON, Oct. 7, 2026 /PRNewswire/ -- MintNeuro, a semiconductor company building specialised chips for neural devices from implants to wearables, today announces a |
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| 2026-10-07 |
VSI® Expands Surgical Capabilities to Meet Growing Patient Demand, Welcomes Spine Surgeon Dr. Alexander Upfill-Brown
HSS-trained orthopedic spine surgeon adds surgical capacity and minimally invasive expertise as more patients seek care at the Reston spine center. RESTON, Va., Oct. 7, 2026 /PRNewswire/ -- VSI Spine Solutions (formerly Virginia Spine Institute) announced that orthopedic spine su |
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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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