| K243303 — Ziehm Vision RFD 3D | Ziehm Imaging GmbH Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242288 — Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243955 — Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243929 — Oligio X | Wontech Co., Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241444 — Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241443 — 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) | Hathor Professional Skincare , Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241910 — Neonav ECG Tip Location System | Navi Medical Technologies Sun Jan 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | Olympus Medical Systems Corporation Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241949 — Digital Color Doppler Ultrasound System (P60 Series) | Sonoscape Medical Corp. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243706 — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243545 — 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 | Philips Medizin Systeme Böblingen GmbH Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242825 — Prenuvo Body Composition | Prenuvo Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243941 — 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) | Access Vascular, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230051 — Myocene | Myocene Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242765 — Electronic Apex Locator (Alpha Apex I) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242064 — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242336 — hygh-tec Drainage II | Amb Medtec Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243249 — TriALTIS Spine System | Medos International SARL Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242860 — Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243606 — Babyroo TN300 | Draeger Medical Systems, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242051 — VersaD Delivery Catheter | Unity Medical, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243935 — Aptima CMV Quant Assay | Hologic, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242608 — Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243067 — The ETHICON Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243605 — Aurora | Ge Medical Systems Israel, Functional Imaging Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243218 — TBS iNsight (V4) | Medimaps Group SA Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242374 — ULSPIRA TS Nitric Oxide Therapy System | Airgas Therapeutics, LLC Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243892 — Affera Integrated Mapping System | Medtronic, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243315 — ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242171 — TechCare Trauma | Milvue Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240217 — cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242705 — 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) | Medtronic, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242522 — Second Opinion CC | Pearl, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241217 — CloudHRV System (100-01-001) | Inmedix, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244048 — Medi Lift Mask | Ya-Man, Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242715 — Pearl Clear Aligner | Pearl Digital, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233770 — Pepper EMS Training System | Pepper Interactive, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243256 — WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241113 — VIVIX-M | Vieworks Co., Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242416 — 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 | Hunan Vathin Medical Instrument Co., Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243289 — ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240197 — cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242834 — System 9 Sterile Battery Container | Stryker Instruments Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |