FDA 510(k) Search and Medical Device Explorer
Search and browse FDA-cleared medical devices, 510(k) submissions, De Novo classifications, PMA records, product codes, review panels, and 21 CFR regulation groupings.
Review Panels
- Anesthesiology (AN)
- Clinical Chemistry (CH)
- Cardiovascular (CV)
- Dental (DE)
- Ear, Nose, Throat (EN)
- Gastroenterology, Urology (GU)
- Hematology (HE)
- General Hospital (HO)
- Immunology (IM)
- Medical Genetics (MG)
- Microbiology (MI)
- Neurology (NE)
- Obstetrics/Gynecology (OB)
- Ophthalmic (OP)
- Orthopedic (OR)
- Pathology (PA)
- Physical Medicine (PM)
- Radiology (RA)
- General, Plastic Surgery (SU)
- Clinical Toxicology (TX)
Recent Decisions
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K261122 | MIST IC | Imagine Milling Technologies, LLC | Jun 27, 2026 |
| K253390 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | Jun 27, 2026 |
| K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | Jun 27, 2026 |
| P250055 | AMDS Hybrid Prosthesis | Artivion, Inc. | Jun 26, 2026 |
| K261745 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | Jun 26, 2026 |
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Jun 26, 2026 |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | Jun 26, 2026 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | Jun 26, 2026 |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | Ziree Co., Ltd. | Jun 26, 2026 |
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Jun 26, 2026 |
| K260714 | MammoScreen® (5) | Therapixel | Jun 26, 2026 |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | Jun 26, 2026 |
| K260061 | BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2) | BioHorizons Implant Systems, Inc. | Jun 26, 2026 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | Jun 26, 2026 |
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | Edwards Lifesciences | Jun 26, 2026 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | Jun 26, 2026 |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | Jun 26, 2026 |
| K253306 | BioTracker 2.0 | Biotracker, LLC | Jun 26, 2026 |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | Jun 26, 2026 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | Jun 25, 2026 |
| K261242 | SimplGuide | Pendracare | Jun 25, 2026 |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | Jun 25, 2026 |
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix | Jun 25, 2026 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | Jun 25, 2026 |
| K260790 | G-Series Grind Guard | ASESSO HEALTH, Inc. | Jun 25, 2026 |
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | Longeviti Neuro Solutions | Jun 25, 2026 |
| K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | Jun 25, 2026 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | Jun 25, 2026 |
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | Jun 25, 2026 |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | Jun 25, 2026 |
