| K250588 — Access Rubella IgG | Beckman Coulter, Inc. Nov 17, 2025 |
| K252086 — DTX Studio Assist | Nobel Biocare C/O Medicim NV Nov 17, 2025 |
| K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Nov 17, 2025 |
| K251566 — TS-RF Generator (STS10) | Starmed Co., Ltd. Nov 17, 2025 |
| K252792 — PM2 System with ECGuide Connector | Piccolo Medical, Inc. Nov 17, 2025 |
| K252330 — DeepRESP | Nox Medical Ehf Nov 17, 2025 |
| K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. Nov 17, 2025 |
| K252618 — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co. , Ltd. Nov 14, 2025 |
| K250501 — System Sophi | This AG Nov 14, 2025 |
| K251756 — Sterilization Trays | Paragon Implant Mfg., LLC Nov 14, 2025 |
| DEN250015 — Neurolyser XR (NXR100) | Fusmobile, Inc. Nov 14, 2025 |
| K250865 — KLS Martin IPS Forearm System | KLS-Martin L.P. Nov 14, 2025 |
| K251821 — ARC-EX System | Onward Medical, Inc. Nov 14, 2025 |
| K250471 — AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC Nov 14, 2025 |
| K252627 — Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. Nov 14, 2025 |
| K251078 — AutoDensity | Eos Imaging Nov 14, 2025 |
| K251538 — Status COVID-19/Flu A&B | Princeton BioMeditech Corp. Nov 14, 2025 |
| K251659 — Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. Nov 14, 2025 |
| K250525 — Second Opinion® Panoramic | Pearl, Inc. Nov 14, 2025 |
| K251872 — Biomoneta Avata Rx | Biomoneta Research Private Limited Nov 14, 2025 |
| K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co., Ltd. Nov 13, 2025 |
| K252949 — Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. Nov 13, 2025 |
| 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 |