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 2, 2026 | K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) Zhengzhou PZ Laser Slim Technology Co., Ltd., CN | GEX |
| Sep 2, 2026 | K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN |
| Sep 2, 2026 | K261311 | HYALOMATRIX Anika Therapeutics, Inc. | QSZ |
| Sep 2, 2026 | K260432 | Ruby Intravascular Catheter Venocare, Inc. | FOZ |
| Sep 2, 2026 | K254198 | Trexo Theo Trexo Robotics, Inc., CA | PHL |
| Sep 2, 2026 | K254090 | I-View® Hologic, Inc. | MUE |
| Sep 2, 2026 | K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large P Flexicare Medical Limited., GB | EOQ |
| Sep 2, 2026 | K253948 | Momentum Acetabular Cup System United Orthopedic Corporation, TW | LZO |
| Sep 2, 2026 | K253065 | Aevumed SUPERCYNCH Button System Aevumed, Inc. | MBI |
| Sep 1, 2026 | K262783 | RadiForce MX247W Eizo Corporation, JP | PGY |
| Sep 1, 2026 | K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
| Sep 1, 2026 | K262451 | Arthrex DynaNite Staples Arthrex, Inc. | JDR |
| Sep 1, 2026 | K262269 | CO2 Laser System (MBT- CO2 Laser) Beijing Mega Beauty Technology Co., Ltd., CN | GEX |
| Sep 1, 2026 | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PRIMED Medical Products, Inc., CA | QSO |
| Sep 1, 2026 | K260884 | UNIDRIVE Select System Karl Storz SE & CO. KG, DE | GCJ |
| Sep 1, 2026 | K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star Siemens Shenzhen Magnetic Resonance , Ltd., CN | LNH |
| Sep 1, 2026 | K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSig GE Healthcare Finland Oy, FI | MHX |
| Sep 1, 2026 | K260613 | AMI Plasma Cartridge, AMI Sequitur Health Corp. | JID |
| Sep 1, 2026 | K253961 | SK Knee System Just Medical Devices (Tianjin) Co., Ltd., CN | JWH |
| Aug 31, 2026 | K262788 | Nova HD+ Aura Wellness, LLC | SGT |
| Aug 31, 2026 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc. | OCC |
| Aug 31, 2026 | K262658 | Automatic Digital Blood Pressure monitor (LD-526) Honsun (Nantong) Co., Ltd., CN | DXN |
| Aug 31, 2026 | K261718 | EZFluence (RADEZ V2) Radformation, Inc. | IYE |
| Aug 31, 2026 | K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) Guilin Kevin Peter Technology Co., Ltd., CN | EBF |
| Aug 31, 2026 | K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter Global Life Sciences Solutions USA, LLC | FPB |
| Aug 31, 2026 | K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS B Kam Yuen Plastic Products , Ltd., CN | OHS |
| Aug 31, 2026 | K260488 | MULTIX Impact; MULTIX Impact C Siemens Medical Solutions USA, Inc. | KPR |
| Aug 31, 2026 | K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) Hironic Co., Ltd., CN | NFO |
| Aug 31, 2026 | K254217 | Aerloom Evolym, LLC | JOW |
| Aug 28, 2026 | K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) Medtronic, Inc. | MXD |
| Aug 28, 2026 | K262722 | Primal K-Wire (P99-193-1410) Paragon 28, Inc. | HTY |
| Aug 28, 2026 | K262013 | Kiba CTO Crossing Catheter Reflow Medical, Inc. | PDU |
| Aug 28, 2026 | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate Sys Ortler Global Tibbi Gerecler Anonim Sirketi, TR | HRS |
| Aug 28, 2026 | K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) Zhengzhou PZ Laser Slim Technology Co., Ltd., CN | NUV |
| Aug 28, 2026 | K261378 | Rayvolve AZchest AZmed, FR | QBS |
| Aug 28, 2026 | K261176 | Zoom 4S Catheter Imperative Care, Inc. | QJP |
| Aug 28, 2026 | K260617 | Tigertriever 13 Ultra Revascularization Device Rapid Medical Ltd., IL | NRY |
| Aug 28, 2026 | K260517 | Automatic Core Biopsy Instrument Zhejiang Curaway Medical Technology Co., Ltd., CN | KNW |
| Aug 28, 2026 | K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display GE Healthcare Finland Oy, FI | MHX |
| Aug 28, 2026 | K260203 | Fule Vertebroplasty Balloon Catheter Beijing Fule Science & Technology Development Co., Ltd., CN | HRX |
| Aug 28, 2026 | K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402 Roche Molecular Systems, Inc. | PGX |
| Aug 28, 2026 | K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Cont Roche Molecular Systems, Inc. | OZN |
| Aug 28, 2026 | K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD., CN | MQL |
| Aug 28, 2026 | K253954 | X-Guide Surgical Navigation System X-Nav Technologies, LLC | QRY |
| Aug 28, 2026 | K253630 | Mpact 3D Metal Foam Medacta International S.A., CH | LPH |
| Aug 27, 2026 | K262744 | GenesisX RMN Stereotaxis, Inc. | DXX |
| Aug 27, 2026 | K262677 | Iconix Knotless T Riverpoint Medical | MBI |
| Aug 27, 2026 | K262654 | Dexus Prosthetic System (MSL2, MSR2) Zhejiang Qiangnao Technology Co.,Ltd, CN | GXY |
| Aug 27, 2026 | K262268 | Optiflow Oxygen Kit (AA484J) Fisher and Paykel Healthcare Limited, NZ | BTT |
| Aug 27, 2026 | K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) Ram.Shaw Pte., Ltd., SG | LRK |