| ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc. | General, Plastic Surgery | 510(k) | 2026-10-21 |
| TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro | Orthopedic | 510(k) | 2026-10-21 |
| Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc. | Clinical Chemistry | 510(k) | 2026-10-21 |
| Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254): 510(k) cleared for Xiamen Compower Medical Tech. Co., Ltd. | Anesthesiology | 510(k) | 2026-10-16 |
| Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set (K263266): 510(k) cleared for Route 92 Medical, Inc. | Cardiovascular | 510(k) | 2026-10-16 |
| TMINI Miniature Robotic System (K263234): 510(k) cleared for THINK Surgical, Inc. | Neurology | 510(k) | 2026-10-16 |
| MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies | Ophthalmic | 510(k) | 2026-10-15 |
| Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd. | Orthopedic | 510(k) | 2026-10-15 |
| Vantage Lumbar Decompression Kit (K263208): 510(k) cleared for SurGenTec, LLC | Orthopedic | 510(k) | 2026-10-14 |
| Electrically Powered Wheelchair (YC-01) (K263257): 510(k) cleared for Yurob Rehabilitation Medical Co., Ltd. | Other | 510(k) | 2026-10-13 |
| CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd. | Neurology | 510(k) | 2026-10-09 |
| One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG | Dental | 510(k) | 2026-10-08 |
| V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Dia | Radiology | 510(k) | 2026-10-08 |
| prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC | Orthopedic | 510(k) | 2026-10-07 |
| InkSpace Imaging Small Body Array (SBA12PH15x) (K262813): 510(k) cleared for Inkspace Imaging, Inc. | Radiology | 510(k) | 2026-10-05 |
| AltiVate Reverse® Glenosphere with RAVN Technology (K263086): 510(k) cleared for Encore Medical L.P. | Orthopedic | 510(k) | 2026-10-02 |
| ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc. | Orthopedic | 510(k) | 2026-10-02 |
| OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies | Orthopedic | 510(k) | 2026-10-02 |
| TDM Large Bone Plate and Screw System (K261611): 510(k) cleared for Tdm Co., Ltd. | Orthopedic | 510(k) | 2026-10-02 |
| Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) (K262412): 510(k) cleared for Barco NV | Radiology | 510(k) | 2026-10-02 |
| Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC | Orthopedic | 510(k) | 2026-10-02 |
| Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® | Microbiology | 510(k) | 2026-10-02 |
| Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical | Cardiovascular | 510(k) | 2026-10-01 |
| NEXUS® Hip Stem (K262473): 510(k) cleared for Microport Orthopedics, Inc. | Orthopedic | 510(k) | 2026-10-01 |
| Dual Stage Venous Cannulae (K263092): 510(k) cleared for Sorin Group Italia S.R.L. | Cardiovascular | 510(k) | 2026-10-01 |
| NOVIX Pedicle Screw System (K263062): 510(k) cleared for Tdm Co., Ltd. | Orthopedic | 510(k) | 2026-10-01 |
| Braun Aura 7 (6041) (K261975): 510(k) cleared for CyDen Limited | General, Plastic Surgery | 510(k) | 2026-09-30 |
| Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (K263033): 510(k) cleared for Fussen Technology Co., Ltd. | Radiology | 510(k) | 2026-09-30 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and Prevention | Microbiology | 510(k) | 2026-09-30 |
| Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-30 |
| SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc. | Orthopedic | 510(k) | 2026-09-30 |
| Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG | Radiology | 510(k) | 2026-09-29 |
| Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC | General, Plastic Surgery | 510(k) | 2026-09-29 |
| Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited | General, Plastic Surgery | 510(k) | 2026-09-25 |
| Arthrex Beaming System (K262975): 510(k) cleared for Arthrex, Inc. | Orthopedic | 510(k) | 2026-09-25 |
| EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd. | Dental | 510(k) | 2026-09-25 |
| EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound | Radiology | 510(k) | 2026-09-25 |
| OsseoFit Stemless Shoulder System (K262955): 510(k) cleared for Zimmer, Inc. | Orthopedic | 510(k) | 2026-09-24 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH | Neurology | 510(k) | 2026-09-24 |
| SABER-C System (K263049): 510(k) cleared for Elevation Spine | Orthopedic | 510(k) | 2026-09-23 |
| BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics | Microbiology | 510(k) | 2026-09-22 |
| Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd. | Dental | 510(k) | 2026-09-21 |
| Toro 71 Aspiration Catheter; Toro Aspiration Tubing (K262021): 510(k) cleared for Toro Neurovascular, Inc. | Cardiovascular | 510(k) | 2026-10-21 |
| BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC | Microbiology | 510(k) | 2026-10-21 |
| SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc. | Microbiology | 510(k) | 2026-10-21 |
| Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc. | Orthopedic | 510(k) | 2026-10-21 |
| INNI-CERA (BCM-W500, BCM-W1000) (K262980): 510(k) cleared for DentMedi Co., Ltd. | Dental | 510(k) | 2026-10-21 |
| Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc. | Clinical Chemistry | 510(k) | 2026-10-20 |
| CINA-Aneurysm (K262062): 510(k) cleared for Avicenna.Ai | Radiology | 510(k) | 2026-10-20 |
| Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC | Dental | 510(k) | 2026-10-20 |
| Accuro XV (K262093): 510(k) cleared for Rivanna Medical, Inc. | Radiology | 510(k) | 2026-10-20 |
| Picosecond Laser treatment system (Z180) (K262628): 510(k) cleared for Sanhe PERFECTLASER Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-20 |
| Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics | Other | 510(k) | 2026-10-20 |
| SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) (K262386): 510(k) cleared for Stryker Instruments | General, Plastic Surgery | 510(k) | 2026-10-20 |
| Rongjian Self-adhesive Electrode (K262664): 510(k) cleared for Bozhou Rongjian Medical Appliance Co., Ltd. | Neurology | 510(k) | 2026-10-20 |
| PDR Airway Device (K262937): 510(k) cleared for Park Dental Research Corp. | Dental | 510(k) | 2026-10-20 |
| AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) (K262932): 510(k) cleared for Shenzhen Accompany Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-19 |
| Reprocessed BRK Transseptal Needle (K262917): 510(k) cleared for Innovative Health, LLC | Cardiovascular | 510(k) | 2026-10-19 |
| CINA-Aneurysm+ (K262147): 510(k) cleared for Avicenna.Ai | Radiology | 510(k) | 2026-10-19 |
| Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc. | Neurology | 510(k) | 2026-10-18 |
| BCS Bioceramic Sealer (K262478): 510(k) cleared for BCS Device Pte., Ltd. | Dental | 510(k) | 2026-10-16 |
| Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) (K262443): 510(k) cleared for Sofradim Production | General, Plastic Surgery | 510(k) | 2026-10-16 |
| Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc. | Ophthalmic | 510(k) | 2026-10-16 |
| Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific | General Hospital | 510(k) | 2026-10-16 |
| KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L. | General, Plastic Surgery | 510(k) | 2026-10-16 |
| MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. | Obstetrics/Gynecology | 510(k) | 2026-10-16 |
| Amber Arte (K262523): 510(k) cleared for Hass Corp. | Dental | 510(k) | 2026-10-16 |
| Giranel Guiding Sheath Set (K262674): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd. | Cardiovascular | 510(k) | 2026-10-15 |
| Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) (K262214): 510(k) cleared for Guangzhou Aimooe Technology Co., Ltd. | Neurology | 510(k) | 2026-10-15 |
| The Circadia CX00 System (CX00) (K262447): 510(k) cleared for Circadia Health, Inc. | Cardiovascular | 510(k) | 2026-10-15 |
| twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. | Clinical Chemistry | 510(k) | 2026-10-15 |
| Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd. | Orthopedic | 510(k) | 2026-10-15 |
| INDIGO® Aspiration System (K262904): 510(k) cleared for Penumbra, Inc. | Cardiovascular | 510(k) | 2026-10-15 |
| da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455): 510(k) cleared for Intuitive Surgical, Inc. | Gastroenterology, Urology | 510(k) | 2026-10-14 |
| CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test (K262432): 510(k) cleared for CorDx, Inc. | Microbiology | 510(k) | 2026-10-14 |
| Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical) | Gastroenterology, Urology | 510(k) | 2026-10-14 |
| 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) (K262885): 510(k) cleared for Guangxi Hope Medical Devices Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-14 |
| Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. | General Hospital | 510(k) | 2026-10-14 |
| Ntegrate Threaded Nail System (K261961): 510(k) cleared for Nvision Biomedical Technologies | Orthopedic | 510(k) | 2026-10-14 |
| Electric Wheelchair (CN501) (K262652): 510(k) cleared for Zhejiang Shimo Technology Co., Ltd. | Other | 510(k) | 2026-10-13 |
| OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd. | Dental | 510(k) | 2026-10-13 |
| IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) (K262352): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-09 |
| Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) (K262068): 510(k) cleared for CathRx, Ltd. | Cardiovascular | 510(k) | 2026-10-09 |
| Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd. | Obstetrics/Gynecology | 510(k) | 2026-10-09 |
| Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc. | Radiology | 510(k) | 2026-10-09 |
| Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500) (K262834): 510(k) cleared for Shenzhen Jianchao Intelligent Technology Co., Ltd. | Other | 510(k) | 2026-10-09 |
| Excelsior Reach Microcatheter (K261649): 510(k) cleared for Stryker Neurovascular | Cardiovascular | 510(k) | 2026-10-09 |
| ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation | Radiology | 510(k) | 2026-10-09 |
| Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw ( | Other | 510(k) | 2026-10-08 |
| Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W | Radiology | 510(k) | 2026-10-08 |
| CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5) (K262346): 510(k) cleared for Wuhan Phomed Technology Co., Ltd | General, Plastic Surgery | 510(k) | 2026-10-08 |
| NEXT-Cue (K261805): 510(k) cleared for Neuroxt, Inc. | Neurology | 510(k) | 2026-10-08 |
| Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) (K262822): 510(k) cleared for Zhongshan GL Electronics Co. , Ltd. | General, Plastic Surgery | 510(k) | 2026-10-07 |
| NeuroDR (K262134): 510(k) cleared for Deep Reasoning Ai, Inc. | Radiology | 510(k) | 2026-10-07 |
| B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention | Microbiology | 510(k) | 2026-10-07 |
| Ligence Heart (K261733): 510(k) cleared for UAB Ligence | Radiology | 510(k) | 2026-10-07 |
| Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc. | Dental | 510(k) | 2026-10-07 |
| Diode Laser Hair Removal Machine (QDTM-03) (K261692): 510(k) cleared for Beijing Nubway S&T Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-07 |
| LOBO Vascular Occlusion System (K262798): 510(k) cleared for Okami Medical, Inc. | Cardiovascular | 510(k) | 2026-10-06 |
| MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike (K262043): 510(k) cleared for Bayer Medical Care, Inc. | Cardiovascular | 510(k) | 2026-10-06 |
| APRO 88 Catheter (K261938): 510(k) cleared for Alembic, LLC | Cardiovascular | 510(k) | 2026-10-06 |
| TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan | General Hospital | 510(k) | 2026-10-06 |
| Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT) (K261887): 510(k) cleared for NormaTec Industries, LP | Other | 510(k) | 2026-10-06 |
| UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35) (K262285): 510(k) cleared for Shijiazhuang Recovery Star Medical Device Co., Ltd. | General, Plastic Surgery | 510(k) | 2026-10-05 |
| RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE | Radiology | 510(k) | 2026-10-05 |
| Glucommander (K261939): 510(k) cleared for Glytec, LLC | Anesthesiology | 510(k) | 2026-10-05 |
| Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9) (K262812): 510(k) cleared for Sichuan Qianli-Beoka Medical Technology, Inc. | Other | 510(k) | 2026-10-05 |
| Plenity-V (MC0979 / GS110) (K261783): 510(k) cleared for Gelesis SRL | Gastroenterology, Urology | 510(k) | 2026-10-02 |
| Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System (K261607): 510(k) cleared for Spinal Simplici | Orthopedic | 510(k) | 2026-10-02 |
| Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc | Radiology | 510(k) | 2026-10-02 |
| Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K261933): 510(k) cleared for GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | Radiology | 510(k) | 2026-10-02 |
| MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris | Gastroenterology, Urology | 510(k) | 2026-10-02 |
| Hemostatic Clip (K261741): 510(k) cleared for Anrei Medical (Hz) Co., Ltd. | Gastroenterology, Urology | 510(k) | 2026-10-02 |
| REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc. | Radiology | 510(k) | 2026-10-02 |
| Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe | General Hospital | 510(k) | 2026-10-01 |
| SwiftSight-BodyComposition (K261612): 510(k) cleared for Airs Medical, Inc. | Radiology | 510(k) | 2026-10-01 |
| Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE | Neurology | 510(k) | 2026-09-30 |
| EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc. | Dental | 510(k) | 2026-09-30 |
| danumed StomaMeter (K262038): 510(k) cleared for Danumed Medizintechnik GmbH | Gastroenterology, Urology | 510(k) | 2026-09-30 |
| Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC | Orthopedic | 510(k) | 2026-09-30 |
| Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V. | Cardiovascular | 510(k) | 2026-09-30 |
| Eonis SMA kit (K262893): 510(k) cleared for Revvity, Inc. | Other | 510(k) | 2026-09-30 |
| NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd. | Orthopedic | 510(k) | 2026-09-29 |
| Electric Wheelchair (0080) (K262241): 510(k) cleared for Xuzhou Heabens Medical Technology Co., Ltd. | Other | 510(k) | 2026-09-29 |
| Power Mobility Scooter (MA03) (K262213): 510(k) cleared for Nanjing Mijo Technology Co., Ltd. | Other | 510(k) | 2026-09-29 |
| MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) (K262553): 510(k) cleared for Zhejiang Kailang Technology Co., Ltd. | Other | 510(k) | 2026-09-29 |
| Spinalogic Bone Growth Stimulator (K262721): 510(k) cleared for Djo, LLC | Orthopedic | 510(k) | 2026-09-29 |
| Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc. | Cardiovascular | 510(k) | 2026-09-29 |
| Alians Forearm (K262649): 510(k) cleared for Newclip Technics | Orthopedic | 510(k) | 2026-09-28 |
| Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc. | General, Plastic Surgery | 510(k) | 2026-09-28 |
| Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L. | Cardiovascular | 510(k) | 2026-09-28 |
| 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC | General Hospital | 510(k) | 2026-09-25 |
| Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd. | Clinical Chemistry | 510(k) | 2026-09-25 |
| Invisalign System (K262196): 510(k) cleared for Align Technology, Inc. | Dental | 510(k) | 2026-09-25 |
| EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC | Radiology | 510(k) | 2026-09-25 |
| corra® cervical plating system (K262149): 510(k) cleared for Carlsmed, Inc. | Orthopedic | 510(k) | 2026-09-24 |
| QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH | Microbiology | 510(k) | 2026-09-24 |
| Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) (K262183): 510(k) cleared for Shenzhen Nuon Medical Equipment Co., Ltd. | Other | 510(k) | 2026-09-24 |
| MPa Max adhesive (K262252): 510(k) cleared for Den-Mat Holdings, LLC | Dental | 510(k) | 2026-09-24 |
| Arthrex Spine Compression FT Screw (K262618): 510(k) cleared for Arthrex, Inc. | Other | 510(k) | 2026-09-24 |
| ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc. | Orthopedic | 510(k) | 2026-09-23 |
| BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc. | Gastroenterology, Urology | 510(k) | 2026-09-23 |
| G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet | Orthopedic | 510(k) | 2026-09-23 |
| Cemented Plus Abutment (K262207): 510(k) cleared for Unidental Co., Ltd. | Dental | 510(k) | 2026-09-23 |
| iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc. | Orthopedic | 510(k) | 2026-09-23 |
| DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd. | Dental | 510(k) | 2026-09-23 |
| Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories | Microbiology | 510(k) | 2026-09-23 |
| Liquick X-treme, Liquick X-treme Plus (K261418): 510(k) cleared for Teleflex Medical | Gastroenterology, Urology | 510(k) | 2026-09-23 |
| Electric wheelchair (GP100) (K262582): 510(k) cleared for Suzhou Green Pine Medical Co., Ltd. | Other | 510(k) | 2026-09-23 |
| Hair Growth Comb (X-GC01) (K262254): 510(k) cleared for Guangdong Ashmore Health Technology Co., Ltd. | Other | 510(k) | 2026-09-23 |