| K251842 — Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. Nov 13, 2025 |
| K251314 — Rosa® Knee System | Orthosoft Inc. (D/B/A) Zimmer CAS Nov 13, 2025 |
| K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Nov 13, 2025 |
| K252308 — LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. Nov 13, 2025 |
| K252592 — TELLTALE Electrosurgical Guidewire System | Telltale, LLC Nov 13, 2025 |
| K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Olympus Medical Systems Corp. Nov 12, 2025 |
| K243715 — Synthes Patient Specific Implants | Synthes GmbH Nov 12, 2025 |
| K251833 — EMPOWR Acetabular® Liner Extension | Encore Medical L.P. Nov 12, 2025 |
| K253290 — XSTAT P15 | Revmedx, Inc. Nov 12, 2025 |
| K252829 — Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. Nov 12, 2025 |
| K252959 — WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A Nov 12, 2025 |
| K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG Nov 12, 2025 |
| K252271 — Hemoclip | Hangzhou AGS MedTech Co., Ltd. Nov 12, 2025 |
| K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. Nov 12, 2025 |
| K252452 — PeekMed web | Peek Health, S.A. Nov 12, 2025 |
| K252287 — Symani Surgical System | Medical Microinstruments, Inc. Nov 10, 2025 |
| K252570 — EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. Nov 10, 2025 |
| K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH Nov 10, 2025 |
| K252474 — Withings BeamO (SCT02) | Withings Nov 10, 2025 |
| K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System | Atlas Spine, Inc. Nov 10, 2025 |
| K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | KLS-Martin L.P. Nov 10, 2025 |
| K251006 — NeVasc Aspiration System | Vesalio, Inc. Nov 10, 2025 |
| K251596 — Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps Nov 9, 2025 |
| K252564 — Medical Diode Laser Systems (VeinCure) | Baoding Te'Anzhou Electronic Technology Co., Ltd. Nov 7, 2025 |
| K250819 — Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV Nov 7, 2025 |
| K250739 — Primeprint Direct Aligner | Dreve Dentamid GmbH Nov 7, 2025 |
| K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY Nov 7, 2025 |
| K251295 — ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG Nov 7, 2025 |
| K251853 — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nov 7, 2025 |
| K252041 — Fibresolve (with PCCP) | Imvaria, Inc. Nov 7, 2025 |
| K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company Nov 7, 2025 |
| K252519 — CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co.,Ltd Nov 7, 2025 |
| K243131 — Triathlon Pro | Sigma Biomedical Nov 7, 2025 |
| K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda Nov 7, 2025 |
| K251391 — BrainsWay Deep TMS System | Brainsway , Ltd. Nov 7, 2025 |
| K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation Nov 7, 2025 |
| K250264 — SugarBug (1.x) | Bench7, Inc. Nov 7, 2025 |
| K250815 — Hubly Drill (H100) | Hubly, Inc. Nov 6, 2025 |
| K253478 — Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. Nov 6, 2025 |
| K252418 — Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. Nov 6, 2025 |
| K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. Nov 6, 2025 |
| K252525 — AIO Breathe | Aiomega, LLC Nov 6, 2025 |
| K250423 — mb-FIX Cranial Stabilization Systems | Medical Bees GmbH Nov 6, 2025 |
| K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. Nov 6, 2025 |
| K253074 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Nov 6, 2025 |
| K252515 — Q-Switched Nd:Yag laser (K690) | Hebei Keylaser Sci-Tech Co.,Ltd Nov 6, 2025 |
| K251555 — Ultra Compression Screw System | Pace Surgical Nov 6, 2025 |
| K253265 — BriefCase-Triage | Aidoc Medical , Ltd. Nov 6, 2025 |
| K252845 — Venus Nova (FP-2001) | Venus Concept, Inc. Nov 6, 2025 |
| K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. Nov 6, 2025 |