| K254223 — Next Generation 088 Catheter | Balt USA, LLC Apr 16, 2026 |
| K251478 — ClearTip TBNA Type | Finemedix Co., Ltd. Apr 16, 2026 |
| K254274 — ARx® SAI Implant System | Life Spine, Inc. Apr 16, 2026 |
| K253537 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | Bright Uro, Inc. Apr 16, 2026 |
| K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | Strauss Surgical USA Apr 16, 2026 |
| K253523 — Freedom DS Decompression System | Spinal Simplicity Apr 16, 2026 |
| K252318 — Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. Apr 16, 2026 |
| K254101 — Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. Apr 16, 2026 |
| K254273 — Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. Apr 16, 2026 |
| K260011 — Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. Apr 16, 2026 |
| K252843 — STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. Apr 15, 2026 |
| K252728 — IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited Apr 15, 2026 |
| K252774 — Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. Apr 15, 2026 |
| K254107 — Refobacin Bone Cement R (110034355) | Biomet France Apr 15, 2026 |
| K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson And Company Apr 15, 2026 |
| K253337 — REGEN Bioactive Cement | Inter-Med, Inc. Apr 15, 2026 |
| K260722 — SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. Apr 15, 2026 |
| K260307 — Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. Apr 15, 2026 |
| K260938 — PATH BGC | Crossroads Neurovascular, Inc. Apr 15, 2026 |
| K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. Apr 15, 2026 |
| K260661 — Midas Restore | Sprintray, Inc. Apr 15, 2026 |
| K252258 — VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla Apr 15, 2026 |
| K260129 — Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Apr 15, 2026 |
| K253573 — ASTar BC G- Kit | Q-Linea AB Apr 15, 2026 |
| K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics Apr 15, 2026 |
| K252663 — Inbentus Versatile | Iconic Solutions By Murcia, SL Apr 14, 2026 |
| K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. Apr 14, 2026 |
| K260498 — TriMemo SEMIRIGID ANNULOPLASTY RING | Corcym S.R.L. Apr 14, 2026 |
| K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. Apr 14, 2026 |
| K260583 — Equinoxe® Shoulder System | Exactech, Inc. Apr 14, 2026 |
| K240974 — SPRINT PNS System | Spr Therapeutics, Inc. Apr 14, 2026 |
| K252587 — HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. Apr 14, 2026 |
| K253502 — Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC Apr 14, 2026 |
| K254078 — HVT 2.0 | Vapotherm, Inc. Apr 13, 2026 |
| K260091 — Aventus Introducer Sheath | Inquis Medical Apr 13, 2026 |
| K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC Apr 13, 2026 |
| K260965 — CVAC Aspiration System | Calyxo, Inc. Apr 13, 2026 |
| K253357 — b-ONE® Bipolar Head | B-One Ortho, Corp. Apr 13, 2026 |
| K252280 — Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics Apr 13, 2026 |
| K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer, Inc. Apr 13, 2026 |
| K253861 — ACORYS MAPPING SYSTEM | Corify Care S.L Apr 13, 2026 |
| K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC Apr 13, 2026 |
| K254128 — InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. Apr 13, 2026 |
| K252757 — CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA Apr 10, 2026 |
| K252190 — DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. Apr 10, 2026 |
| K260508 — LOBO Vascular Occlusion System | Okami Medical, Inc. Apr 10, 2026 |
| K253510 — Freestyle Mini Hands-free | Medela, LLC Apr 10, 2026 |
| K252942 — ShaeferH | Shaeferh, LLC Apr 10, 2026 |
| K260090 — SMART Osteotomy System | Actis Medical Pty., Ltd. Apr 10, 2026 |
| K260839 — Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. Apr 10, 2026 |