510(k) Clearances — Page 4
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,607 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K260918 — Zolid Lunaris | Amann Girrbach AG Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261122 — MIST IC | Imagine Milling Technologies, LLC Sat Jun 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253301 — BraiN20® (BraiN20) | Time IS Brain, S.L. Sat Jun 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253390 — SOMNUM (SOMNUM) | Honeynaps Co., Ltd. Sat Jun 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261745 — LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261455 — Arterial Pressure Monitoring Set/Tray | Spectrum Vascular Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260018 — Arthrex FiberButton | Arthrex, Inc. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253921 — VERTICALE® Navigation Instruments | Silony Medical GmbH Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261351 — SALGINA 2.5mm Distal Radius System | Bonebridge AG Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253306 — BioTracker 2.0 | Biotracker, LLC Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253316 — PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261039 — i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260061 — BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260714 — MammoScreen® (5) | Therapixel Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254108 — Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253216 — IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253274 — BedDot (G1) | Intelligent Dots, LLC Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251188 — UNIQA® Dental Implants System | Uniqa Dental, Ltd. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260231 — MiPACS V5 (1.0.0) | Apryse Software Corp Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260480 — VELYS Robotic-Assisted Solution | Depuy Ireland UC Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253367 — EliA CTD 13 Screen | Phadia AB Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261242 — SimplGuide | Pendracare Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253786 — syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253384 — mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260790 — G-Series Grind Guard | ASESSO HEALTH, Inc. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261025 — Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253386 — DVT Garment | Vistar Medical Supplies Co., Ltd. Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260992 — iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix Thu Jun 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261866 — Concerto Versa Detachable Coil | Medtronic, Inc. Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261260 — HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261055 — AMSCO 700 Steam Sterilizer | STERIS Corporation Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252117 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261023 — Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260998 — Ceribell Neurology Review Software | Ceribell, Inc. Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261772 — Target Xtra Detachable Coil | Stryker Neurovscular Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253404 — CLEAR Aspiration System | Insera Therapeutics, Inc. Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253263 — ConvaVAC Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd Wed Jun 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |