| Revi System (K252391) | Bluewind Medical , Ltd. | 2025-12-12 |
| Jason membrane (K242817) | Botiss Biomaterials GmbH | 2025-12-12 |
| Bio Arterial Deluxe (IC-BAP-DX) (K250974) | Bio Compression Systems, Inc. | 2025-12-12 |
| Fundus On Phone Non Mydriatic (FOP NM-10) (K252120) | Remidio Innovative Solutions Private Limited | 2025-12-12 |
| VizMark Preloaded Tissue Marker Device (VM-0001) (K251989) | Breast-Med, Inc. | 2025-12-12 |
| Affixus® Natural Nail® Proximal Humeral System (K253749) | Zimmer Switzerland Manufacturing GmbH | 2025-12-12 |
| HyperFlex® Bunion Correction System (K252997) | Hyperflex Medical | 2025-12-11 |
| CogNet AI-MT+ (K252482) | Medcognetics, Inc. | 2025-12-11 |
| KLS Martin Pure Pectus System (K250988) | KLS-Martin L.P. | 2025-12-11 |
| Target Detachable Coil (K252694) | Stryker Neurovascular | 2025-12-11 |
| APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista (K252897) | A Plus Biotechnology Co., Ltd. | 2025-12-11 |
| Cervical Spine Truss System - Stand Alone (CSTS-SA) (K253200) | 4Web Medical, Inc. | 2025-12-11 |
| HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (K252941) | O&M Halyard, Inc. | 2025-12-11 |
| MIM – LesionID Pro (K251883) | Mim Software, Inc. | 2025-12-11 |
| DeepRhythmAI (K253141) | Medicalgorithmics S.A. | 2025-12-11 |
| Verisafe Safety Retractable Insulin Syringes (K250192) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| ARIX Femur Nail System (K252826) | Jeil Medical Corporation | 2025-12-10 |
| Intellidrop (K251598) | Brainspace, Inc. | 2025-12-10 |
| SANSA HSAT (K252497) | Huxley Medical | 2025-12-10 |
| GlasIonomer FX-LC (K252808) | Shofu Dental Corporation | 2025-12-09 |
| Lancing device (HH-XV-T) (K253706) | Tianjin Huahong Technology Co., Ltd. | 2025-12-09 |
| Allia Moveo (K251199) | GE Medical Systems SCS | 2025-12-09 |
| Atlantis® Abutments in Titanium (K252343) | Dentsply Sirona | 2025-12-09 |
| Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) (K252154) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 |
| Focused Cryotherapy System (K250742) | Focused Cryo, Inc. | 2025-12-09 |
| DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (K250805) | Devilbiss Healthcare, LLC | 2025-12-09 |
| INFINITT DPS (K243449) | Infinitt Healthcare Co., Ltd. | 2025-12-09 |
| Ceribell Delirium Monitor System (K251936) | Ceribell, Inc. | 2025-12-08 |
| HeartBeam AIMIGo with 12-L ECG Synthesis Software System (K250258) | Heartbeam, Inc. | 2025-12-08 |
| Glass Ceramic (K252789) | Shenzhen Xiangtong Co., Ltd. | 2025-12-08 |
| DeGen Medical Patient Specific Implant (PSI) System (K251829) | Degen Medical | 2025-12-08 |
| Electric Wheelchair (DH01126) (K252862) | Foshan Dahao Medical Technology Co., Ltd. | 2025-12-08 |
| Sequential Compression System (SCD600) (K250190) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-08 |
| Fetal EchoScan (v1.2) (K252294) | Brightheart | 2025-12-08 |
| LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) (K252994) | Guangdong Ace-Tec Co., Ltd. | 2025-12-08 |
| Gastric Alimetry (K252504) | Alimetry , Ltd. | 2025-12-05 |
| Remvia NightGuard (K250743) | Remvia | 2025-12-05 |
| Manual Wheelchair (W45) (K252825) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| Augmented Gingival Matrix (K250512) | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 2025-12-05 |
| Velora Acetabular System (K252067) | Restor3D, Inc. | 2025-12-05 |
| Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (K252142) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-05 |
| SpineLinc Anterior Cervical Implant System (K250764) | Lincotek Medical | 2025-12-05 |
| PUREVUE™ FMS (K250795) | W.O.M. World of Medicine GmbH | 2025-12-05 |
| Overjet CBCT Assist (K251514) | Overjet, Inc. | 2025-12-05 |
| Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) (K251403) | Dornier Medtech America Inc (Dmta) | 2025-12-05 |
| Manual Wheelchair (W47) (K252828) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (K251337) | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-12-05 |
| REAL INTELLIGENCE™ CORI™ XT (CORI XT) (K252841) | Blue Belt Technologies, Inc. | 2025-12-05 |
| Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) (K252498) | Sonoscape Medical Corp. | 2025-12-05 |
| ARTAssistant (K250780) | Manteia Technologies Co., Ltd. | 2025-12-05 |
| QuietLab Pro (K253868) | QuietLab, LLC | 2025-12-05 |
| els unibond (K252151) | Saremco Dental AG | 2025-12-05 |
| Personalized Therapy Comfort Settings (PTCS) (K251657) | Resmed Corp | 2025-12-05 |
| VSP Orthopedics System (K250711) | 3D Systems, Inc. | 2025-12-05 |
| mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (K252605) | Medspira, LLC | 2025-12-05 |
| KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (K251731) | Karl Storz SE & CO. KG | 2025-12-05 |
| OncoPatch (K252296) | Oncopatch, Inc. | 2025-12-05 |
| Electrically powered wheelchair (KZ301B) (K252494) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-12-05 |
| MEMO Patch M (MPT-E08R-UNC01) (K243438) | Huinno Co., Ltd. | 2025-12-05 |
| Any-Core (K252465) | Mediclus Co., Ltd. | 2025-12-05 |
| ProSeal™ Transfer Injector (421120, 421130, 421140) (K251722) | Epic Medical Pte. , Ltd. | 2025-12-05 |
| MitraPatch Mitral Valve Repair System (K252126) | Chawla Heart Technologies, LLC | 2025-12-04 |
| ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| Vektor Computational ECG Mapping System (vMap®) (K252429) | Vektor Medical, Inc. | 2025-12-04 |
| Mobility Scooter (T5) (K252588) | Zhejiang Taotao Vehicle Co., Ltd. | 2025-12-04 |
| FFX Facet Fixation System (K250679) | Sc Medica | 2025-12-04 |
| Tigon Medical Knotless and Dual Javelin All-Suture Anchors (K252596) | Tigon Medical | 2025-12-04 |
| Spineology Navigation Instruments (K251943) | Spineology, Inc. | 2025-12-04 |
| nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (K251257) | Np Medical | 2025-12-04 |
| ASUS Ultrasound Imaging System (LU800 series) (K250791) | Asustek Computer, Inc. | 2025-12-04 |
| GentleBeam (GB1000) (K250692) | Voxel Ray Solutions, LLC | 2025-12-03 |
| Hugo™ RAS System (K250725) | Covidien, LLC | 2025-12-03 |
| Bendit17 Microcatheter (K252213) | Bend IT Technologies, Ltd. | 2025-12-03 |
| HippoMind (v1.0) (K251881) | Hippoclinic | 2025-12-03 |
| Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (K250564) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 |
| Omnipod 5 algorithm (K251779) | Insulet Corporation | 2025-12-03 |
| Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem (K251601) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-12-03 |
| VitaloJAK Clinic (Model 7100) (K253293) | Vitalograph , Ltd. | 2025-12-03 |
| AVIEW Lung Nodule CAD (K251203) | Coreline Soft Co., Ltd. | 2025-12-03 |
| 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (K250884) | Becton, Dickinson and Company | 2025-12-02 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K252103) | Mighty Oak Medical | 2025-12-02 |
| da Vinci SP Surgical System (SP1098) (K252069) | Intuitive Surgical, Inc. | 2025-12-02 |
| Aura Wave (K250896) | Aura Wellness, LLC | 2025-12-02 |
| Disposable Endoscopic Injection Needles (K252021) | Changzhou New Med Micro-Medtech Co., Ltd. | 2025-12-02 |
| Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713) | Exactech, Inc. | 2025-12-01 |
| Minuteman® G6 MIS Fusion Plate (K253250) | Spinal Simplicity, LLC | 2025-12-01 |
| Led Light Phototherapy Bed (Pro 450/ GY-680A) (K252786) | Shenzhen Suyzeko Limited. | 2025-12-01 |
| Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) (K251691) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| Cartesion Prime (PCD-1000A/3) V10.21 (K251370) | Canon Medical Systems Corporation | 2025-12-01 |
| Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) (K251696) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) (K252827) | Drägerwerk AG & Co. KGaA | 2025-12-01 |
| Medical Diode Laser Systems (TR-B) (K252658) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025-11-28 |
| Dendrite Imaging System (K253303) | Dendrite Imaging, Inc. | 2025-11-28 |
| Sophy Mini Monopressure Valve (SM1) (K250636) | Sophysa | 2025-11-28 |
| CT VScore+ (K252217) | Canon Medical Informatics, Inc. | 2025-11-28 |
| Carriere® Motion Pro® Clear Bite Corrector (K252760) | Ortho Organizers, Inc. | 2025-11-27 |
| Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (K251697) | ACON Laboratories, Inc. | 2025-11-26 |
| uDR Arria & uDR Aris (K252000) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 |
| RELIEEV HSG Catheter (HSG7FA1) (K252260) | Li Medical Corporation , Ltd. | 2025-11-26 |
| OEC One CFD (K253269) | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 |