| K252627 — Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252618 — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co. , Ltd. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251756 — Sterilization Trays | Paragon Implant Mfg., LLC Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250471 — AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250865 — KLS Martin IPS Forearm System | KLS-Martin L.P. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251821 — ARC-EX System | Onward Medical, Inc. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250501 — System Sophi | This AG Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250015 — Neurolyser XR (NXR100) | Fusmobile, Inc. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251078 — AutoDensity | Eos Imaging Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251538 — Status COVID-19/Flu A&B | Princeton BioMeditech Corp. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251659 — Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250525 — Second Opinion® Panoramic | Pearl, Inc. Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251872 — Biomoneta Avata Rx | Biomoneta Research Private Limited Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251842 — Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252949 — Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251314 — Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252308 — LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252592 — TELLTALE Electrosurgical Guidewire System | Telltale, LLC Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243715 — Synthes Patient Specific Implants | Synthes GmbH Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251833 — EMPOWR Acetabular® Liner Extension | Encore Medical L.P. Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252829 — Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253290 — XSTAT P15 | Revmedx, Inc. Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252959 — WRISTAR MultiAx Distal Radius Kit | Intrauma S.P.A Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252271 — Hemoclip | Hangzhou AGS MedTech Co., Ltd. Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252452 — PeekMed web | Peek Health, S.A. Wed Nov 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252287 — Symani Surgical System | Medical Microinstruments, Inc. Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252570 — EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252474 — Withings BeamO (SCT02) | Withings Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System | Atlas Spine, Inc. Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251006 — NeVasc Aspiration System | Vesalio, Inc. Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251596 — Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps Sun Nov 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251295 — ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252564 — Medical Diode Laser Systems (VeinCure) | Baoding Te'Anzhou Electronic Technology Co., Ltd. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250739 — Primeprint Direct Aligner | Dreve Dentamid GmbH Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250819 — Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252041 — Fibresolve (with PCCP) | Imvaria, Inc. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252519 — CO2 Laser Therapy System (K106) | Hebei Keylaser Sci-Tech Co.,Ltd Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243131 — Triathlon Pro | Sigma Biomedical Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251391 — BrainsWay Deep TMS System | Brainsway , Ltd. Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |