| K251812 — Steripath® Flow Blood Collection System | Magnolia Medical Technologies Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251971 — RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | Stryker Instruments Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251465 — Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250016 — Essilor® Stellest® | Essilor Of America, Inc. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250076 — Endeavor Stand-Alone Cervical IBF System | Innovasis Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251993 — Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | Covidien, LLC Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | Yung Sheng Optical Co., Ltd. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251734 — ProVee Video Processing Unit (PV-003) | Proverum Limited Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252689 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252682 — LenSx Laser System (8065000944) | Alcon Laboratories, Inc. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250071 — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | Alma Lasers, Inc. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250792 — t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243910 — Retraxil | Kulzer, LLC Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252183 — Resitu Slider 09 (RESL09) | Resitu Medical AB Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252227 — Pounce(TM) Sheath | Surmodics,Inc. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250045 — uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Boston Scientific Corporation Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251206 — Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252680 — Celerity 20 HP Biological Indicator | STERIS Corporation Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251894 — Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251483 — SwiftSight-Brain | Airs Medical, Inc. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250209 — Polyvinyl Alcohol Embolic Microspheres | Canyon Medical, Inc. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240080 — Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252644 — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Olympus Winter & Ibe GmbH Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251987 — Rapid Aortic Measurements | Ischemaview, Inc. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252045 — Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251973 — Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251140 — Zenflow Spring Scope | Zenflow, Inc. Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250388 — ENDOFLATOR + | Karl Storz SE & CO. KG Mon Sep 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251743 — SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. Mon Sep 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252315 — Santreva-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. Mon Sep 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250205 — Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co., Ltd. Mon Sep 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243645 — IC-Flow Imaging System 2.0 | Diagnostic Green GmbH Mon Sep 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250777 — Sonicaid Team3 | Huntleigh Healthcare , Ltd. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243920 — Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241868 — xR IVD | Tempus AI, Inc. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252613 — Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252647 — Tapestry Biointegrative Implant | Embody, Inc. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240067 — KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250450 — Coated hip implants | Medacta International S.A. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252662 — UniBur | Nakanishi, Inc. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250128 — Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |