| K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) | Fit-Pro KFT (Ltd.) - DBA E-Fit | 2026-09-27 |
| K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | 2026-09-27 |
| K263182 | 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 System; EVO XC10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2026-09-25 |
| K262983 | EsTemp Implant | Spident Co., Ltd. | 2026-09-25 |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | 2026-09-25 |
| K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | 2026-09-25 |
| K262215 | Profoject™ Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | 2026-09-25 |
| K262196 | Invisalign System | Align Technology, Inc. | 2026-09-25 |
| K261992 | 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | 2026-09-25 |
| K261977 | Braun Aura 9 (6042) | Cyden Limited | 2026-09-25 |
| K261372 | Profoject™ LOR Syringe | CMT Health PTE., Ltd. | 2026-09-25 |
| K261336 | Xpert Respiratory Panel | Cepheid | 2026-09-25 |
| K261262 | Altis Full Face Mask | Respironics, Inc. | 2026-09-25 |
| K260140 | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | 2026-09-25 |
| K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | 2026-09-25 |
| K260023 | TumorSight Risk | SimBioSys, Inc. | 2026-09-25 |
| K254297 | Tempus ECG-MR | Tempus AI, Inc. | 2026-09-25 |
| K254291 | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges | Ezisurg Medical Co., Ltd. | 2026-09-25 |
| K254255 | S-Patch CardioAI | Wellysis Corp. | 2026-09-25 |
| K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | Karl Storz SE & CO. KG | 2026-09-25 |
| K254230 | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | 2026-09-25 |
| K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | Hyundai Bioland Co., Ltd. | 2026-09-25 |
| K254058 | DistaSense(TM) (v1) | Life Detection Technologies | 2026-09-25 |
| K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | 2026-09-24 |
| K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2026-09-24 |
| K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026-09-24 |
| K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | 2026-09-24 |
| K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2026-09-24 |
| K262168 | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | 2026-09-24 |
| K262149 | corra® cervical plating system | Carlsmed, Inc. | 2026-09-24 |
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026-09-24 |
| K261078 | Electric Scooter (FNS01,FNS03) | Anhui Jbh Medical Apparatus Co., Ltd. | 2026-09-24 |
| K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | 2026-09-24 |
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | 2026-09-24 |
| K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | 2026-09-24 |
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026-09-24 |
| K254303 | KARL STORZ SUPRALOOP | Karl Storz SE & CO. KG | 2026-09-24 |
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | 2026-09-24 |
| K263049 | SABER-C System | Elevation Spine | 2026-09-23 |
| K262582 | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | 2026-09-23 |