The Tracker // February 2026
February 2026: 222 FDA device decisions
217 510(k) clearances and 5 original PMA approvals with a decision date in February 2026. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Feb 27, 26 | K251998510(k) | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | Clinical Chemistry | CIG |
| Feb 27, 26 | K252448510(k) | AViTA Pulse Oximeter (SP61) | Avita Corporation | Cardiovascular | DQA |
| Feb 27, 26 | K252714510(k) | C-Lant Port | Vigor Medical Technologies , Ltd. | Gastroenterology, Urology | GCJ |
| Feb 27, 26 | K253535510(k) | Ligence Heart | Ligence Uab | Radiology | QIH |
| Feb 27, 26 | K253536510(k) | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | Ear, Nose, Throat | ETN |
| Feb 27, 26 | K253695510(k) | LigaMend | Riverpoint Medical, LLC | Orthopedic | MBI |
| Feb 27, 26 | K253778510(k) | Allday Moisturizing Rinse | Elevate Oral Care | Unknown | LFD |
| Feb 27, 26 | K253797510(k) | One-Stop | Mediclus Co., Ltd. | Unknown | MVL |
| Feb 27, 26 | K253828510(k) | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Feb 27, 26 | K253829510(k) | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Feb 27, 26 | K254249510(k) | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | Orthopedic | HRS |
| Feb 27, 26 | K260292510(k) | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | Cardiovascular | DXF |
| Feb 26, 26 | K251700510(k) | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm | Speciality Fibres and Materials Limited | Unknown | QSY |
| Feb 26, 26 | K251860510(k) | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | General, Plastic Surgery | FYA |
| Feb 26, 26 | K252166510(k) | RIB LINK Fixation System | Globus Medical, Inc. | Orthopedic | HRS |
| Feb 26, 26 | K253021510(k) | ANNE Maternal | Sibel Health, Inc. | Obstetrics/Gynecology | HGM |
| Feb 26, 26 | K253328510(k) | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | Orthopedic | MBH |
| Feb 26, 26 | K253578510(k) | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | Radiology | QAS |
| Feb 26, 26 | K253641510(k) | Owl Night Guard | Owl Dental Lab, Inc. | Unknown | OBR |
| Feb 26, 26 | K253764510(k) | ENOS Software Guided External Fixation System | Disior, Ltd. | Orthopedic | OSN |
| Feb 26, 26 | K253791510(k) | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. | General Hospital | KCT |
| Feb 26, 26 | K254017510(k) | SWINGO-3D Lumbar Cage System | Implanet | Orthopedic | MAX |
| Feb 26, 26 | K254182510(k) | Aster | Osteonic Co., Ltd. | Orthopedic | KWQ |
| Feb 26, 26 | K254242510(k) | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | Gastroenterology, Urology | OWN |
| Feb 26, 26 | K254251510(k) | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | Obstetrics/Gynecology | HIH |
| Feb 26, 26 | K254271510(k) | CAPRI | ORO Co., Ltd. | General, Plastic Surgery | GEX |
| Feb 26, 26 | K260254510(k) | Enbio PRO | Enbio Group AG | General Hospital | FLE |
| Feb 26, 26 | P250028PMA | Synergy Disc | Synergy Spine Solutions, Inc. | Orthopedic | MJO |
| Feb 25, 26 | K251687510(k) | Konig Bell Circumcision Clamp | Medline Industries, LP | Obstetrics/Gynecology | HFX |
| Feb 25, 26 | K251724510(k) | Remi Impression Material | Grindguard, Inc. | Dental | SHI |
| Feb 25, 26 | K253472510(k) | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | Orthopedic | PQC |
| Feb 25, 26 | K253559510(k) | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | Orthopedic | OVD |
| Feb 25, 26 | K253789510(k) | Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. | Physical Medicine | ITI |
| Feb 25, 26 | K253996510(k) | BD Surgiphor Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | General Hospital | FQH |
| Feb 25, 26 | K260222510(k) | Mako Total Knee Application | Mako Surgical Corp. | Neurology | OLO |
| Feb 24, 26 | K251678510(k) | Swift Ray 1 | Swift Medical, Inc. | General, Plastic Surgery | QJF |
| Feb 24, 26 | K252599510(k) | Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics , Ltd. | General, Plastic Surgery | GEX |
| Feb 24, 26 | K253186510(k) | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | Cardiovascular | DQK |
| Feb 24, 26 | K253707510(k) | Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | Physical Medicine | ITI |
| Feb 24, 26 | K253714510(k) | IntraSight Plus | Philips Image Guided Therapy Corporation | Radiology | IYO |
| Feb 24, 26 | K253978510(k) | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | Gastroenterology, Urology | GCJ |
| Feb 24, 26 | K254055510(k) | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | Orthopedic | MAI |
| Feb 24, 26 | K254247510(k) | OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. | Orthopedic | NKB |
| Feb 24, 26 | K254267510(k) | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | Cardiovascular | JOW |
| Feb 24, 26 | K260217510(k) | AI Platform 2.2 (AIP002) | Exo Imaging | Radiology | QIH |
| Feb 24, 26 | K260287510(k) | SP Electrocautery Device (SP20) | Single Pass, Inc. | General, Plastic Surgery | GEI |
| Feb 24, 26 | K260377510(k) | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | General, Plastic Surgery | GEH |
| Feb 23, 26 | K251587510(k) | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Dental | KLE |
| Feb 23, 26 | K251661510(k) | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | Anesthesiology | MNS |
| Feb 23, 26 | K251864510(k) | Rubber Utility Catheter | C.R. Bard, Inc. | Gastroenterology, Urology | KOD |
| Feb 23, 26 | K252795510(k) | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | Argon Medical Devices, Inc. | Gastroenterology, Urology | KNW |
| Feb 23, 26 | K253068510(k) | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | General Hospital | FMF |
| Feb 23, 26 | K253169510(k) | Duet Spinal Fixation System | Box Spine, LLC | Orthopedic | NKB |
| Feb 23, 26 | K253228510(k) | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Cardiovascular | DXN |
| Feb 23, 26 | K253244510(k) | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | Radiology | IZL |
| Feb 23, 26 | K253486510(k) | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | Radiology | LLZ |
| Feb 23, 26 | K253531510(k) | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Applied Medical Resources Corporation | General, Plastic Surgery | KGW |
| Feb 23, 26 | K253583510(k) | LUX Expandable Lumbar Interbody System | Xenix Medical | Orthopedic | MAX |
| Feb 23, 26 | K253631510(k) | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | Physical Medicine | INI |
| Feb 23, 26 | K253648510(k) | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | Radiology | LNH |
| Feb 23, 26 | K253666510(k) | IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | General, Plastic Surgery | OHT |
| Feb 23, 26 | K260043510(k) | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | Cardiovascular | DWF |
| Feb 23, 26 | K260265510(k) | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | LNH |
| Feb 22, 26 | K253646510(k) | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | Gastroenterology, Urology | FDT |
| Feb 21, 26 | K251692510(k) | Advanced Tissue Resection Device | Micro-Tech (Nanjing) Co., Ltd. | Gastroenterology, Urology | FDI |
| Feb 20, 26 | K251653510(k) | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | Neurology | OBP |
| Feb 20, 26 | K251890510(k) | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Gastroenterology, Urology | FAD |
| Feb 20, 26 | K252500510(k) | CARA System | Cara Medical, Ltd. | Radiology | OWB |
| Feb 20, 26 | K252619510(k) | QSCHECK UISACR | Qstag, Inc. | Clinical Chemistry | JFY |
| Feb 20, 26 | K252672510(k) | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | Casebioscience, Inc. | Obstetrics/Gynecology | MQL |
| Feb 20, 26 | K252972510(k) | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | Cardiovascular | DQK |
| Feb 20, 26 | K252989510(k) | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | Neurology | OLO |
| Feb 20, 26 | K253445510(k) | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | Bd | General Hospital | FQH |
| Feb 20, 26 | K253605510(k) | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | General, Plastic Surgery | FMK |
| Feb 20, 26 | K253653510(k) | Xpert Hemorrhagic Fever | Cepheid | Unknown | |
| Feb 20, 26 | K253660510(k) | KLS Martin Pure Pectus System | KLS-Martin L.P. | Orthopedic | HRS |
| Feb 20, 26 | K253683510(k) | FAQ (LED Panel); FAQ (Dual LED Panel) | Foreo, Inc. | General, Plastic Surgery | OHS |
| Feb 20, 26 | K254162510(k) | KLS Martin Ixos System | KLS Martin L.P. | Orthopedic | HRS |
| Feb 20, 26 | K260181510(k) | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | General Hospital | JOJ |
| Feb 20, 26 | P250023PMA | Allurion Gastric Balloon System | Allurion Technologies, Inc. | Gastroenterology, Urology | LTI |
| Feb 19, 26 | K251903510(k) | Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation | Physical Medicine | NHN |
| Feb 19, 26 | K252002510(k) | Monaco RTP System (6.3) | Elekta Solutions AB | Radiology | MUJ |
| Feb 19, 26 | K252597510(k) | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | Neurology | OLO |
| Feb 19, 26 | K252733510(k) | ATLAS Expandable Osteotomy Wedge System | MiRus, LLC | Orthopedic | PLF |
| Feb 19, 26 | K252814510(k) | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe | CMT Health PTE., Ltd. | General Hospital | QNQ |
| Feb 19, 26 | K253002510(k) | SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | General, Plastic Surgery | QAI |
| Feb 19, 26 | K253203510(k) | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | Cardiovascular | DWF |
| Feb 19, 26 | K253398510(k) | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | General, Plastic Surgery | FXX |
| Feb 19, 26 | K253612510(k) | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | Ear, Nose, Throat | PNZ |
| Feb 19, 26 | K253623510(k) | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co KG | Neurology | OLO |
| Feb 19, 26 | K253687510(k) | Access anti-HBc Total | Beckman Coulter, Inc. | Microbiology | SEI |
| Feb 19, 26 | K254018510(k) | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | Dental | EHD |
| Feb 19, 26 | K254148510(k) | VERTICALE GPS Instruments | Silony Medical GmbH | Neurology | OLO |
| Feb 19, 26 | K254188510(k) | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | General, Plastic Surgery | GAT |
| Feb 19, 26 | K260163510(k) | AuST CSP Introducer | CenterPoint Systems, LLC | Cardiovascular | DYB |
| Feb 19, 26 | K260205510(k) | AS Software Version Asera | AS Software, LLC | Radiology | LLZ |
| Feb 19, 26 | K260218510(k) | LacertaMatrix | Lacerta Life Sciences | Unknown | KGN |
| Feb 19, 26 | K260308510(k) | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | Radiology | MUJ |
| Feb 18, 26 | K252098510(k) | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | General Hospital | MEG |
| Feb 18, 26 | K252197510(k) | Nobel Biocare S Series Implants | Nobel Biocare AB | Dental | DZE |
| Feb 18, 26 | K252561510(k) | BTL-754FF | BTL Industries, Inc. | General, Plastic Surgery | GEX |
| Feb 18, 26 | K253539510(k) | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | Clinical Chemistry | NBC |
| Feb 18, 26 | K253637510(k) | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Orthopedic | MBH |
| Feb 18, 26 | K253643510(k) | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | Physical Medicine | INI |
| Feb 18, 26 | K260185510(k) | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | Gastroenterology, Urology | GCJ |
| Feb 17, 26 | K250550510(k) | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation | Gastroenterology, Urology | FDS |
| Feb 17, 26 | K251680510(k) | Biosteon® Screw | Biocomposites, Ltd. | Orthopedic | MAI |
| Feb 17, 26 | K252805510(k) | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Cardiovascular | DQA |
| Feb 17, 26 | K253524510(k) | Adaptos®Fuse Bone Graft | Biomendex OY | Orthopedic | MQV |
| Feb 17, 26 | K253599510(k) | Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co.,Ltd | Physical Medicine | ITI |
| Feb 17, 26 | K254089510(k) | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical, Inc. | Cardiovascular | DQK |
| Feb 17, 26 | K260149510(k) | Versus Catheter (VS110-9NB) | Liquet Medical, Inc. | Cardiovascular | QEY |
| Feb 13, 26 | K243854510(k) | Contour Light (CL-100) | Contour Research, LLC | General, Plastic Surgery | OLI |
| Feb 13, 26 | K250233510(k) | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | Cardiovascular | DXH |
| Feb 13, 26 | K251581510(k) | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | Cardiovascular | DXN |
| Feb 13, 26 | K251619510(k) | Babyleo TN500 | Drägerwerk AG & Co. KGaA | General Hospital | FMZ |
| Feb 13, 26 | K251742510(k) | VELO Respiratory Test | Lex Diagnostics Limited | Microbiology | QOF |
| Feb 13, 26 | K251802510(k) | STAR RF Ablation System | Merit Medical Systems, Inc. | Neurology | GXI |
| Feb 13, 26 | K251852510(k) | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. | Gastroenterology, Urology | OWN |
| Feb 13, 26 | K251928510(k) | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. | General, Plastic Surgery | GEH |
| Feb 13, 26 | K252400510(k) | Endomina EZFuse system | Endo Tools Therapeutics S.A. | Gastroenterology, Urology | OCW |
| Feb 13, 26 | K252420510(k) | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Feb 13, 26 | K252422510(k) | Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Feb 13, 26 | K252512510(k) | Armada 14 NC PTA Catheter | ABBOTT MEDICAL | Cardiovascular | LIT |
| Feb 13, 26 | K252565510(k) | PreOp v3 | Clouds of Care | Neurology | OLX |
| Feb 13, 26 | K252685510(k) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co. , Ltd. | Cardiovascular | DXN |
| Feb 13, 26 | K252891510(k) | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | Cardiovascular | DXT |
| Feb 13, 26 | K253089510(k) | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. | Cardiovascular | DXQ |
| Feb 13, 26 | K253092510(k) | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | Cardiovascular | DXG |
| Feb 13, 26 | K253096510(k) | Chartis Precision Catheter | Pulmonx Corporation | Anesthesiology | CBI |
| Feb 13, 26 | K253133510(k) | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | Cardiovascular | DXN |
| Feb 13, 26 | K253149510(k) | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | Obstetrics/Gynecology | HGX |
| Feb 13, 26 | K253564510(k) | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
| Feb 13, 26 | K254052510(k) | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | Ophthalmic | LPL |
| Feb 13, 26 | K254105510(k) | Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC | Orthopedic | ODP |
| Feb 13, 26 | K260130510(k) | Willow 18 Guidewire | Arbor Endovascular, LLC | Cardiovascular | MOF |
| Feb 12, 26 | K251375510(k) | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | General Hospital | FPA |
| Feb 12, 26 | K251732510(k) | Wrist Fracture System | Met One Technologies, LLC | Orthopedic | HRS |
| Feb 12, 26 | K251760510(k) | Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare , Ltd. | Gastroenterology, Urology | KPI |
| Feb 12, 26 | K252490510(k) | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | General, Plastic Surgery | FMK |
| Feb 12, 26 | K252523510(k) | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | Clinical Toxicology | NFW |
| Feb 12, 26 | K253201510(k) | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | Orthopedic | KWQ |
| Feb 12, 26 | K253354510(k) | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. | Obstetrics/Gynecology | MQF |
| Feb 12, 26 | K253381510(k) | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | Neurology | OLO |
| Feb 12, 26 | K253490510(k) | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | Clinical Chemistry | CFR |
| Feb 12, 26 | K253491510(k) | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics | Clinical Chemistry | CEM |
| Feb 12, 26 | K253972510(k) | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | Gastroenterology, Urology | OWN |
| Feb 12, 26 | K254007510(k) | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. | General, Plastic Surgery | OHS |
| Feb 12, 26 | K260108510(k) | L12 LED Light Source with AIM | Stryker Endoscopy | Gastroenterology, Urology | OWN |
| Feb 12, 26 | K260177510(k) | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | Gastroenterology, Urology | GCJ |
| Feb 12, 26 | P220031PMA | LimiFlex Dynamic Sagittal Tether | Empirical Spine, Inc. | Orthopedic | SGK |
| Feb 11, 26 | DEN250007510(k) | Delivery Date AI | Ultrasound AI | Radiology | SHE |
| Feb 11, 26 | K251592510(k) | SteriHub Disinfecting Device and Protective Cover | 1World Vista Medical | General Hospital | QBP |
| Feb 11, 26 | K251813510(k) | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | General, Plastic Surgery | GEI |
| Feb 11, 26 | K251992510(k) | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | Radiology | OWB |
| Feb 11, 26 | K252084510(k) | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | Radiology | QIH |
| Feb 11, 26 | K253032510(k) | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | Cardiovascular | QJP |
| Feb 11, 26 | K253049510(k) | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Radiology | IYN |
| Feb 11, 26 | K253488510(k) | iFuse INTRA Ti Implant System | SI-BONE, Inc. | Orthopedic | OUR |
| Feb 11, 26 | P250034PMA | Optune Pax | Novocure, GmbH | General, Plastic Surgery | SHC |
| Feb 10, 26 | K251515510(k) | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | Dental | NHA |
| Feb 10, 26 | K251672510(k) | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | Ear, Nose, Throat | ETN |
| Feb 10, 26 | K252175510(k) | LANDR Contact LENS Case | Fourth Axis, LLC | Ophthalmic | LRX |
| Feb 10, 26 | K252179510(k) | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only | Shenzhen RF Tech Co., Ltd. | Radiology | MOS |
| Feb 10, 26 | K252459510(k) | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | Gastroenterology, Urology | KDI |
| Feb 10, 26 | K252751510(k) | Earflo (EF001) | Earflo, Inc. | Unknown | MJV |
| Feb 10, 26 | K253140510(k) | CollOvine Wound Powder | Ovigenex, LLC | Unknown | KGN |
| Feb 10, 26 | K253545510(k) | Vulcan Spinal System | K2m, Inc. | Orthopedic | NKB |
| Feb 10, 26 | K254016510(k) | MI View&GO | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
| Feb 10, 26 | K260073510(k) | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | Orthopedic | JDW |
| Feb 10, 26 | K260119510(k) | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | Radiology | OVB |
| Feb 10, 26 | P240045PMA | Optimum Infinite (tisilfocon A) Orthokeratology Lenses II | Contamac, Ltd. | Ophthalmic | NUU |
| Feb 9, 26 | K251591510(k) | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | Cardiovascular | DQK |
| Feb 9, 26 | K254033510(k) | Ceribell Instant EEG Headset | Ceribell, Inc. | Neurology | GXY |
| Feb 9, 26 | K254236510(k) | Peel-Away Introducer Sheath | VascuTech Medical, LLC | Cardiovascular | DYB |
| Feb 6, 26 | DEN250006510(k) | Amferia Wound Dressing | Amferia AB | General, Plastic Surgery | SHA |
| Feb 6, 26 | K243348510(k) | Athelas Home | Athelas, Inc. | Hematology | GKZ |
| Feb 6, 26 | K243979510(k) | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | Immunology | MSV |
| Feb 6, 26 | K251218510(k) | SafeBeat Rx App | SafeBeat Rx, Inc. | Cardiovascular | DQK |
| Feb 6, 26 | K251423510(k) | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | Obstetrics/Gynecology | HGX |
| Feb 6, 26 | K251474510(k) | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | Radiology | QDQ |
| Feb 6, 26 | K251507510(k) | INTEGRE LIO | Quantel Medical | Ophthalmic | HQF |
| Feb 6, 26 | K251543510(k) | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | Clinical Chemistry | JLW |
| Feb 6, 26 | K251577510(k) | LAIA XR | Augmented Reality Software S.L. | Radiology | LLZ |
| Feb 6, 26 | K251614510(k) | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | General Hospital | KCT |
| Feb 6, 26 | K251836510(k) | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | General, Plastic Surgery | GEI |
| Feb 6, 26 | K252058510(k) | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | Neurology | OLO |
| Feb 6, 26 | K252076510(k) | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | Cardiovascular | DQD |
| Feb 6, 26 | K252726510(k) | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | Cardiovascular | MHX |
| Feb 6, 26 | K252871510(k) | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | Neurology | OLO |
| Feb 6, 26 | K252873510(k) | Q Interbody Instruments | K2m, Inc. | Neurology | OLO |
| Feb 6, 26 | K253221510(k) | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | Radiology | IYO |
| Feb 6, 26 | K253568510(k) | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Fujifilm Corporation | Gastroenterology, Urology | FDS |
| Feb 6, 26 | K253780510(k) | SIGNA Bolt | Ge Medical Systems, LLC | Radiology | LNH |
| Feb 6, 26 | K253852510(k) | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | General, Plastic Surgery | GAM |
| Feb 6, 26 | K253927510(k) | LiveMedica Enterprise PACS | Live Medica, LLC | Radiology | LLZ |
| Feb 5, 26 | K251517510(k) | Encora X1 | Encora, Inc. | Neurology | QBC |
| Feb 5, 26 | K251949510(k) | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | Cardiovascular | QEW |
| Feb 5, 26 | K253779510(k) | SIGNA Sprint Select | Ge Medical Systems, LLC | Radiology | LNH |
| Feb 5, 26 | K253959510(k) | Primevision 3D | Dentsply Sirona | Radiology | OAS |
| Feb 5, 26 | K260028510(k) | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Argon Medical Devices, Inc. | Cardiovascular | QEW |
| Feb 4, 26 | K250773510(k) | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | Orthopedic | MAX |
| Feb 4, 26 | K252301510(k) | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | General, Plastic Surgery | FYA |
| Feb 4, 26 | K252623510(k) | G7® Revision Acetabular System | Zimmer, Inc. | Orthopedic | LPH |
| Feb 4, 26 | K260012510(k) | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | Cardiovascular | PNO |
| Feb 4, 26 | K260038510(k) | E3D-C Interbody System | Evolution Spine | Orthopedic | OVE |
| Feb 4, 26 | K260104510(k) | Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | Orthopedic | QHE |
| Feb 3, 26 | K250644510(k) | MSS - Monobloc stem | Medacta International S.A. | Orthopedic | PHX |
| Feb 3, 26 | K252048510(k) | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Feb 3, 26 | K252087510(k) | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | Neurology | OLO |
| Feb 3, 26 | K252438510(k) | Explant Express | Applied Medical Technology, Inc. | General, Plastic Surgery | QVS |
| Feb 3, 26 | K252676510(k) | The Circadia C300 System (C300) | Circadia Health, Inc. | Cardiovascular | DRT |
| Feb 3, 26 | K252909510(k) | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | Dental | EHD |
| Feb 3, 26 | K253282510(k) | ZSmile System | Dror Orthodesign , Ltd. | Dental | NXC |
| Feb 3, 26 | K253640510(k) | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | Orthopedic | HSB |
| Feb 3, 26 | K253701510(k) | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | Clinical Chemistry | QJI |
| Feb 3, 26 | K253737510(k) | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | Clinical Chemistry | QBJ |
| Feb 2, 26 | K251200510(k) | Vital Signs | Oxehealth Limited | Cardiovascular | QME |
| Feb 2, 26 | K251582510(k) | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Unknown | FRO |
| Feb 2, 26 | K252011510(k) | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | Cardiovascular | MOF |
| Feb 2, 26 | K252286510(k) | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | Dental | DZE |
| Feb 2, 26 | K252649510(k) | TAP2D | Nano-X Imaging , Ltd. | Radiology | IZF |
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
September 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.