| Xenco Medical CancelleX Cervical Interbody System (K243673) | Xenco Medical, LLC | 2025-01-29 |
| Digital Video Processor (K243117) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-29 |
| Versalock Upper Limb Plating System (K243740) | GM Dos Reis Industria e Comercio Ltda. | 2025-01-29 |
| Self-Forming Magnet (FLEX SFM) (K243213) | GI Windows, Inc. | 2025-01-29 |
| GYDER® Hip System (K243387) | Gyder Surgical Pty, Ltd. | 2025-01-29 |
| Argo Knotless GENESYS Anchor (K244025) | Conmed Corporation | 2025-01-28 |
| Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (K243698) | Brainlab AG | 2025-01-28 |
| 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K243501) | 3M Company | 2025-01-28 |
| HemosIL CL HIT-IgG(PF4-H) (K243374) | Instrumentation Laboratory (IL) Co. | 2025-01-28 |
| LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (K243423) | Shenzhen Rainbow Technology Co., Ltd. | 2025-01-28 |
| Medical Monitor (27HS714S) (K243439) | Lg Electronics.Inc | 2025-01-28 |
| SANSA HSAT (K244027) | Huxley Medical | 2025-01-28 |
| CO2 Laser Therapy Systems (SHE-LSP003-1) (K242941) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-01-27 |
| Bunkerhill AVC (K243229) | BunkerHill Health | 2025-01-27 |
| Firstar Dental Unit (K231297) | Firstar Dental Company | 2025-01-27 |
| Imaging system of positron emission and X-ray computed tomography (DigitMI 930) (K241266) | Raysolution Healthcare Co., Ltd. | 2025-01-27 |
| Symani Surgical System (820-03830) (K250014) | Medical Microinstruments, Inc. | 2025-01-27 |
| Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220) | Roche Diagnostics Operations | 2025-01-24 |
| Galen™ Second Read™ (K241232) | Ibex Medical Analytics , Ltd. | 2025-01-24 |
| ClearPoint System (Software Version 3.0) (K243657) | ClearPoint Neuro, Inc. | 2025-01-24 |
| Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) (K241107) | Indiba S. A. U. | 2025-01-24 |
| OrganProtex HTK Solution (K241239) | Bridge TO Life, Ltd. | 2025-01-24 |
| MAGENTIQ-COLO (ME-APDS) (K244023) | Magentiq Eye, Ltd. | 2025-01-24 |
| Bone Marrow Biopsy Needle (K242322) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (K241793) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (K241057) | Wuhan Guangdun Technology Co.,Ltd.. | 2025-01-24 |
| AxCess® Expandable Interbody System (K243739) | Elliquence, LLC | 2025-01-24 |
| MONARCH™ Platform (MON-000008) (K243219) | Auris Health, Inc. | 2025-01-23 |
| TeraRecon Aorta.CT (1.1.0) (K243158) | Terarecon,Inc. | 2025-01-23 |
| Rotatable Connector (5944RL) (K241199) | Shenzhen Launch Electrical Co., Ltd. | 2025-01-23 |
| RF Cannula (K241367) | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2025-01-23 |
| Acu-Sinch Knotless Mini (K243624) | Acumed, LLC | 2025-01-23 |
| Mobility Scooter (S-01); Mobility Scooter (S-02) (K242714) | Zhejiang Seedream Medical Equipment Co., Ltd. | 2025-01-23 |
| OTS 25-L (100-5) (K241234) | Ots Medical , Ltd. | 2025-01-23 |
| CephNinja (K241819) | Cyncronus, LLC | 2025-01-23 |
| ProLift Pivot Expandable Spacer System (K243668) | Life Spine, Inc. | 2025-01-23 |
| Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (K241728) | Murata Vios, Inc. | 2025-01-23 |
| Rapid Neuro3D (K243350) | Ischemaview, Inc. | 2025-01-22 |
| Reverso Pro System (K243139) | Indiba S. A. U. | 2025-01-22 |
| Nicolet EDX (K243982) | Natus Neurology Incorporated | 2025-01-22 |
| ZeroClear™ Bag Access (423100) (K243976) | Epic Medical Pte. , Ltd. | 2025-01-22 |
| JETT Medical II (K240311) | Compex, Spol, S.R.O. | 2025-01-22 |
| Arthrex NanoScope System (K243008) | Arthrex, Inc. | 2025-01-22 |
| Rio™ Drug Reconstitution Transfer Device (K243985) | Icu Medical, Inc. | 2025-01-22 |
| Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) (K241956) | Hunan Endoso Life Technology Co., Ltd. | 2025-01-22 |
| Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K242446) | Persyst Development Corporation | 2025-01-22 |
| Suture-TOOL System (K242835) | Suturion AB | 2025-01-22 |
| XT3 System (K241357) | Biodynamik, Inc. | 2025-01-22 |
| EMPHASYS Acetabular System (K243977) | Depuy Ireland UC | 2025-01-22 |
| Advanced Cryo Wart Remover (K242288) | Medical Brands Laboratories B.V. | 2025-01-21 |
| Oligio X (K243929) | Wontech Co., Ltd. | 2025-01-21 |
| Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (K241443) | Hathor Professional Skincare , Ltd. | 2025-01-21 |
| Precision AI Surgical Planning System (PAI-SPS) (K243955) | Precision AI Pty, Ltd. | 2025-01-21 |
| Biliary Pancreaticobiliary Scope System (K241444) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-01-21 |
| Ziehm Vision RFD 3D (K243303) | Ziehm Imaging GmbH | 2025-01-21 |
| Neonav ECG Tip Location System (K241910) | Navi Medical Technologies | 2025-01-19 |
| HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (K243941) | Access Vascular, Inc. | 2025-01-17 |
| Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (K242705) | Medtronic, Inc. | 2025-01-17 |
| TBS iNsight (V4) (K243218) | Medimaps Group SA | 2025-01-17 |
| mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (K241261) | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 |
| Prenuvo Body Composition (K242825) | Prenuvo | 2025-01-17 |
| Embozene Color-Advanced Microspheres (K242608) | Varian Medical Systems, Inc. | 2025-01-17 |
| Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333) | Koh Young Technology, Inc. | 2025-01-17 |
| Digital Color Doppler Ultrasound System (P60 Series) (K241949) | Sonoscape Medical Corp. | 2025-01-17 |
| ProGrip™ Self-Gripping Polypropylene Mesh (K243315) | Sofradim Production | 2025-01-17 |
| Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (K242064) | Smart Denture Conversions, LLC | 2025-01-17 |
| Babyroo TN300 (K243606) | Draeger Medical Systems, Inc. | 2025-01-17 |
| ULSPIRA TS™ Nitric Oxide Therapy System (K242374) | Airgas Therapeutics, LLC | 2025-01-17 |
| Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn (K243545) | Philips Medizin Systeme Böblingen GmbH | 2025-01-17 |
| mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (K241142) | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 |
| Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (K243706) | Medtronic Sofamor Danek, Inc. | 2025-01-17 |
| Electronic Apex Locator (Alpha Apex I) (K242765) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-01-17 |
| EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) (K243502) | Olympus Medical Systems Corporation | 2025-01-17 |
| Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (K243568) | Wilson-Cook Medical, Inc. | 2025-01-17 |
| Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291) | Neoventa Medical AB | 2025-01-17 |
| Aurora (K243605) | Ge Medical Systems Israel, Functional Imaging | 2025-01-17 |
| Type 5 Integrating Indicator for Steam (CSPN-15) (K242860) | True Indicating, LLC | 2025-01-17 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| Myocene (DEN230051) | Myocene | 2025-01-17 |
| TriALTIS™ Spine System (K243249) | Medos International SARL | 2025-01-17 |
| TechCare Trauma (K242171) | Milvue | 2025-01-17 |
| VersaD Delivery Catheter (K242051) | Unity Medical, Inc. | 2025-01-17 |
| mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (K241269) | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 |
| cobas® liat CT/NG nucleic acid test (K240217) | Roche Molecular Systems, Inc. | 2025-01-17 |
| hygh-tec Drainage II (K242336) | Amb Medtec | 2025-01-17 |
| The ETHICON™ Total Energy System (K243067) | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | 2025-01-17 |
| Affera Integrated Mapping System (K243892) | Medtronic, Inc. | 2025-01-17 |
| Alere NT-proBNP for Alinity i Reagent Kit (K241176) | Axis-Shield Diagnostics, Ltd. | 2025-01-16 |
| Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (K242416) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-16 |
| Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736) | Deka Research and Development Corp. | 2025-01-16 |
| ADDNOX (BPSPM1) (K243289) | Nu Eyne Co., Ltd. | 2025-01-16 |
| Second Opinion CC (K242522) | Pearl, Inc. | 2025-01-16 |
| System 9 Sterile Battery Container (K242834) | Stryker Instruments | 2025-01-16 |
| Medi Lift Mask (K244048) | Ya-Man, Ltd. | 2025-01-16 |
| cobas® liat CT/NG/MG nucleic acid test (K240197) | Roche Molecular Systems, Inc. | 2025-01-16 |
| Pearl Clear Aligner (K242715) | Pearl Digital, Inc. | 2025-01-16 |
| Cala kIQ (K243848) | Cala Health, Inc. | 2025-01-16 |
| WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (K243256) | Wondfo USA Co, Ltd. | 2025-01-16 |
| VIVIX-M (K241113) | Vieworks Co., Ltd. | 2025-01-16 |
| CloudHRV™ System (100-01-001) (K241217) | Inmedix, Inc. | 2025-01-16 |