Latest 510(k) clearances
Newest first, 50 per page. Open a clearance to see any recalls that name it.
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K261715 | Emboliner Embolic Protection System (EPC-03) Emboline, Inc. | PUM |
| Sep 8, 2026 | K261462 | LANDMARK Total Knee System Smith & Nephew, Inc. | MBH |
| Sep 8, 2026 | K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Gmp Medicare Sdn. Bhd., MY | LZA |
| Sep 8, 2026 | K260229 | Electric wheelchair (HC819N, HC830N, HC831N) Yongkang Hengyi Vehicle Co., Ltd., CN | ITI |
| Sep 8, 2026 | K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H DRTECH Corporation, KR | KPR |
| Sep 8, 2026 | K260062 | MODI System DreaMed Diabetes, Ltd., IL | QRX |
| Sep 8, 2026 | K260053 | Power Wheelchair (OS-R-M01I) Beijing OrionStar Technology Co., Ltd., CN | ITI |
| Sep 8, 2026 | K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYU Zhejiang Geyi Medical Instrument Co., Ltd., CN | HIH |
| Sep 8, 2026 | K253988 | LiteSet Trays Nobel Biocare AB, SE | KCT |
| Sep 6, 2026 | K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-30 Shenzhen Osto Medical Technology Co.,Ltd, CN | NUH |
| Sep 6, 2026 | K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) Fidelity BioPharma Co. | OBP |
| Sep 5, 2026 | K261684 | FreezeSpray TA Cryosurgery, Inc. | MLY |
| Sep 5, 2026 | K254135 | LipoSurg ARTIST NOUVAG AG, CH | QPB |
| Sep 4, 2026 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD S.M.A.I.O, FR | NKB |
| Sep 4, 2026 | K262292 | Gastric Alimetry Alimetry , Ltd., NZ | MYE |
| Sep 4, 2026 | K262277 | 70 NeuGlide Catheter Piraeus Medical, Inc. | QJP |
| Sep 4, 2026 | K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCu Medtronic Xomed, Inc. | PGW |
| Sep 4, 2026 | K262130 | ATTUNE Revision Knee System Depuy Orthopaedics, Inc. | JWH |
| Sep 4, 2026 | K262060 | 3D-RD-S Radiopharmaceutical Imaging & Dosimetry, LLC | LLZ |
| Sep 4, 2026 | K261935 | Surgical and Prosthetic Trays Dentsply Sirona, Inc. | KCT |
| Sep 4, 2026 | K261057 | ActivaScrew Cannulated COM Bioretec, Ltd., FI | HWC |
| Sep 4, 2026 | K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) Sentinel Medical Technologies, | EZL |
| Sep 4, 2026 | K260525 | NextMR Spine MRI2CT, Inc. | QIH |
| Sep 4, 2026 | K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) Siemens Healthcare Diagnostics Products, Ltd., GB | DHB |
| Sep 4, 2026 | K260035 | Digital Indeflator INFLANTE UAB Telemedicina, LT | MAV |
| Sep 4, 2026 | K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | QVF |
| Sep 4, 2026 | K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA Ortho Clinical Diagnostics Inc. (QuidelOrtho) | PSZ |
| Sep 4, 2026 | K253909 | NeoPEX Pre-Mixed Obturation Paste NuSmile, Ltd. | KIF |
| Sep 4, 2026 | K253836 | FCT iStream Phase 2 Fujifilm Corporation, JP | JAK |
| Sep 4, 2026 | K253529 | Peerbridge COR MDx (Cor MDx) Peerbridge Health, Inc. | MWJ |
| Sep 3, 2026 | K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) Orthocon, Inc. | MTJ |
| Sep 3, 2026 | K262460 | Rezum System Boston Scientific | KNS |
| Sep 3, 2026 | K262315 | NeuroBlate System Monteris Medical | ONO |
| Sep 3, 2026 | K262243 | Profisil Free Kettenbach GmbH & Co. KG, DE | LBH |
| Sep 3, 2026 | K261800 | Helo Max Thrombectomy System (HEL2090) Endovascular Engineering | QEW |
| Sep 3, 2026 | K261647 | Tempo Plating System; Ultra Compression Screw System Pace Surgical | HRS |
| Sep 3, 2026 | K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Philips Consumer Lifestyle B.V., NL | HGX |
| Sep 3, 2026 | K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 Filmecc Co., Ltd., JP | DQX |
| Sep 3, 2026 | K260503 | Triton 1 System Neptune Medical, Inc. | FDF |
| Sep 3, 2026 | K254035 | Mayumi Thrombectomy System MicroVention, Inc., d/b/a Terumo Neuro | QEZ |
| Sep 3, 2026 | K254000 | Happy Health Blood Pressure Monitor Happy Health, Inc. | DXN |
| Sep 3, 2026 | K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water ba Maxigen Biotech, Inc., TW | NUC |
| Sep 3, 2026 | K253673 | Mcare System (MW-20) Marani Health, Inc. | LQK |
| Sep 3, 2026 | K251794 | Tenax® Laser Resistant Endotracheal Tube Bryan Medical, Inc. | BTR |
| Sep 3, 2026 | DEN250044 | Queen of Hearts (ACS AI ECG Model) Powerful Medical, Inc. | SHS |
| Sep 2, 2026 | K262809 | ArthroTAK Tendon Anchor Kit ArthroTAK, LLC | MBI |
| Sep 2, 2026 | K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) Serpex Medical | GEH |
| Sep 2, 2026 | K262364 | Ellian Enigma RF Device Ellian Corp | GEI |
| Sep 2, 2026 | K262153 | Pivot Insulin Delivery System Modular Medical, Inc. | LZG |
| Sep 2, 2026 | K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Cardinalhealth | LZA |