| K253970 — Wovyn Depth Electrode | Sensomedical Labs, Ltd. Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260934 — TITAN Nail; APTUS K-Wire System | Medartis AG Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260929 — Neonav ECG Tip Location System | Navi Medical Technologies Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252237 — EdgeFlow UW20 | Edgecare, Inc. Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260696 — MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253907 — Disposable Radiofrequency Cannula | ABBOTT MEDICAL Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254216 — Enso for Migraine | Hinge Health, Inc. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252317 — Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253260 — ORIO-3D Cage System | SpineCraft Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251658 — Endoflux Biliary & Pancreatic Stent Sets | Medi-Globe GmbH Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253804 — DESS Dental Smart Solutions | Terrats Medical SL Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260020 — Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260903 — Hot Pink Pad Warming System | Xodus Medical, Inc. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254223 — Next Generation 088 Catheter | Balt USA, LLC Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251478 — ClearTip TBNA Type | Finemedix Co., Ltd. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254274 — ARx® SAI Implant System | Life Spine, Inc. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253523 — Freedom DS Decompression System | Spinal Simplicity Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252318 — Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254101 — Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254273 — Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260011 — Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252728 — IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254107 — Refobacin Bone Cement R (110034355) | Biomet France Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252843 — STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252774 — Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson and Company Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253337 — REGEN Bioactive Cement | Inter-Med, Inc. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260722 — SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260307 — Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260938 — PATH BGC | Crossroads Neurovascular, Inc. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260661 — Midas Restore | Sprintray, Inc. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252258 — VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260129 — Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253573 — ASTar BC G- Kit | Q-Linea AB Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics Wed Apr 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252663 — Inbentus Versatile | Iconic Solutions by Murcia, SL Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260498 — TriMemo SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260583 — Equinoxe® Shoulder System | Exactech, Inc. Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240974 — SPRINT PNS System | Spr Therapeutics, Inc. Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252587 — HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253502 — Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC Tue Apr 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260091 — Aventus Introducer Sheath | Inquis Medical Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254078 — HVT 2.0 | Vapotherm, Inc. Mon Apr 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |