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 30, 2026 | K263172 | SAS MIS Pelvic Incidence Rods Spinal Alignment Solutions, Inc. | NKB |
| Sep 30, 2026 | K263035 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Ki Centers for Disease Control and Prevention | OZE |
| Sep 30, 2026 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) Fussen Technology Co., Ltd., CN | OAS |
| Sep 30, 2026 | K262893 | Eonis SMA kit Revvity, Inc. | QUE |
| Sep 30, 2026 | K262712 | Duet Spinal Fixation System Duet Spine Holdings, LLC | NKB |
| Sep 30, 2026 | K262621 | Rapid Barostat Bag (RBB) Pump and Catheter System Mui Scientific, Inc., CA | FFX |
| Sep 30, 2026 | K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine Brainlab SE, DE | OLO |
| Sep 30, 2026 | K262038 | danumed StomaMeter Danumed Medizintechnik GmbH, DE | KNT |
| Sep 30, 2026 | K261975 | Braun Aura 7 (6041) CyDen Limited, GB | OHT |
| Sep 30, 2026 | K261663 | EzSensor HD Qpix Solutions, Inc. | MUH |
| Sep 30, 2026 | K261469 | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). Barco N.V., BE | DXJ |
| Sep 30, 2026 | K261327 | Elos Accurate Hybrid Base Elos Medtech Pinol A/S, DK | NHA |
| Sep 30, 2026 | K254302 | ECG Analysis Software (AiTiALVSD) Medical AI Co., Ltd., KR | QYE |
| Sep 29, 2026 | K263073 | Fast Absorbing PGLA Riverpoint Medical, LLC | GAM |
| Sep 29, 2026 | K263048 | Syngo Carbon Space (VA4) Siemens Healthineers AG, DE | LLZ |
| Sep 29, 2026 | K262726 | NeckTune SA Cervical Cage Medyssey Co., Ltd., KR | OVE |
| Sep 29, 2026 | K262721 | Spinalogic Bone Growth Stimulator Djo, LLC | LOF |
| Sep 29, 2026 | K262553 | MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) Zhejiang Kailang Technology Co., Ltd., CN | INI |
| Sep 29, 2026 | K262241 | Electric Wheelchair (0080) Xuzhou Heabens Medical Technology Co., Ltd., CN | ITI |
| Sep 29, 2026 | K262213 | Power Mobility Scooter (MA03) Nanjing Mijo Technology Co., Ltd., CN | INI |
| Sep 29, 2026 | K262015 | Elucid FFR-IQ (B.1) Elucid Bioimaging, Inc. | PJA |
| Sep 29, 2026 | K261225 | CAS-One IR Cascination AG, CH | JAK |
| Sep 29, 2026 | K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) QT Medical, Inc. | DPS |
| Sep 29, 2026 | K260031 | THERMEO® I MSI Pro3Dure Medical GmbH, DE | MQC |
| Sep 29, 2026 | DEN260007 | SmartRead(TM) Medical Device Identifier (4100) BridgeSource Medical Corporation | SJJ |
| Sep 28, 2026 | K262649 | Alians Forearm Newclip Technics, FR | HRS |
| Sep 28, 2026 | K262052 | Tri Stage Venous Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Sep 28, 2026 | K261543 | Phasix ST Parastomal Hernia Mesh Davol, Inc., A Subsidiary of C.R. Bard, Inc. | OWT |
| Sep 28, 2026 | K260619 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) Biomérieux, Inc. | LON |
| Sep 28, 2026 | K260474 | Liora Monofilament Scaffold TELA Bio, Inc. | FTL |
| Sep 27, 2026 | K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);U Fit-Pro KFT (Ltd.) - DBA E-Fit, HU | |
| Sep 27, 2026 | K252139 | Kentrospine Viktr-MIS® Pedicle screw system Rivarp Medical Pvt., Ltd., IN | NKB |
| Sep 25, 2026 | K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP Samsung Medison Co., Ltd., KR | IYN |
| Sep 25, 2026 | K262983 | EsTemp Implant Spident Co., Ltd., KR | EMA |
| Sep 25, 2026 | K262975 | Arthrex Beaming System Arthrex, Inc. | HWC |
| Sep 25, 2026 | K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Philips Ultrasound, LLC | IYN |
| Sep 25, 2026 | K262215 | Profoject Safety Sliding Blood Collection Set CMT Health PTE., Ltd., SG | JKA |
| Sep 25, 2026 | K262196 | Invisalign System Align Technology, Inc. | PNN |
| Sep 25, 2026 | K261992 | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) Solventum US, LLC | JOJ |
| Sep 25, 2026 | K261977 | Braun Aura 9 (6042) Cyden Limited, GB | OHT |
| Sep 25, 2026 | K261372 | Profoject LOR Syringe CMT Health PTE., Ltd., SG | CAZ |
| Sep 25, 2026 | K261336 | Xpert Respiratory Panel Cepheid | QOF |
| Sep 25, 2026 | K261262 | Altis Full Face Mask Respironics, Inc. | BZD |
| Sep 25, 2026 | K260140 | Aevice Wheeze Detection Module Aevice Health Pte. , Ltd., SG | PHZ |
| Sep 25, 2026 | K260055 | syngo.CT Brain Quantification Siemens Medical Solutions USA, Inc. | QIH |
| Sep 25, 2026 | K260023 | TumorSight Risk SimBioSys, Inc. | SHW |
| Sep 25, 2026 | K254297 | Tempus ECG-MR Tempus AI, Inc. | SBQ |
| Sep 25, 2026 | K254291 | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Cu Ezisurg Medical Co., Ltd., CN | GDW |
| Sep 25, 2026 | K254255 | S-Patch CardioAI Wellysis Corp., KR | DPS |
| Sep 25, 2026 | K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205 Karl Storz SE & CO. KG, DE | HIH |