| K243302 — 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. May 21, 2025 |
| K251276 — Swoop® Portable MR Imaging® System | Hyperfine, Inc. May 21, 2025 |
| K242637 — MEM Clear Aligner System | Mem Dental Technology Co., Ltd. May 21, 2025 |
| K251230 — The Alma Hybrid Laser System | Alma Lasers, Inc. May 21, 2025 |
| K242527 — The Karma® Fixation System | Spinal Elements, Inc. May 21, 2025 |
| K250602 — X-PAC® N-GAGE Lumbar Plate System | Expanding Innovations, Inc. May 20, 2025 |
| K242485 — EveryWare | Breas Medical AB May 20, 2025 |
| K250370 — SCENARIA View Phase 5.0 | Fujifilm Corporation May 20, 2025 |
| K250199 — VitalFlow Console | Medtronic, Inc. May 20, 2025 |
| K250489 — FP3D | Keystone Industries May 20, 2025 |
| K250534 — Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. May 20, 2025 |
| K250866 — Sovereign Posterior Cervical System | Met One Technologies, LLC May 20, 2025 |
| K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | Flexicare Medical Limited. May 20, 2025 |
| K251231 — ViewFlex X ICE Catheter, Sensor Enabled | ABBOTT MEDICAL May 20, 2025 |
| K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson And Company May 19, 2025 |
| K250456 — Dentemp Pro-Comfort Dental Guard | Doc Brands, Inc. May 19, 2025 |
| K250390 — CloSYS® Dry Mouth Sensitive Mouth Rinse | Rowpar Pharmaceuticals, Inc. May 19, 2025 |
| K243301 — MapRT | Vision Rt, Ltd. May 19, 2025 |
| K242755 — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. May 19, 2025 |
| K243411 — Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. May 19, 2025 |
| K250038 — Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. May 19, 2025 |
| K250122 — SleepRight Snore Aid | Splintek, Inc. May 19, 2025 |
| K243643 — restor3d Reverse Total Shoulder Arthroplasty System | Restor3D May 19, 2025 |
| K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. May 19, 2025 |
| K250020 — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. May 19, 2025 |
| K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. May 19, 2025 |
| K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.P.A. May 16, 2025 |
| K250110 — Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. May 16, 2025 |
| K242731 — MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. May 16, 2025 |
| K242585 — Cystatin C | SENTINEL CH. SpA May 16, 2025 |
| K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. May 16, 2025 |
| K250971 — Embosphere Microspheres | Biosphere Medical, S.A. May 16, 2025 |
| K243105 — Ruby Intravascular Catheter | Venocare, Inc. May 16, 2025 |
| K243617 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. May 16, 2025 |
| K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. May 16, 2025 |
| K241581 — Hemodialysis Catheter | Haolang Medical USA Corporation May 16, 2025 |
| K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. May 16, 2025 |
| K242438 — Clearo | Breas Medical AB May 16, 2025 |
| K250086 — OTS Hip | Ortoma AB May 16, 2025 |
| K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | Encore Medical L.P. May 16, 2025 |
| K243837 — iBSM | Iorbit Digital Technologies Private Limited May 16, 2025 |
| K240554 — InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. May 16, 2025 |
| K244008 — Spectral CT | Philips Medical Systems Technologies , Ltd. May 16, 2025 |
| K250141 — Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. May 16, 2025 |
| K243602 — Arthrex Spine Endoscope | Arthrex, Inc. May 16, 2025 |
| K243176 — BLESSING System | Cellah Medical Co., Ltd. May 16, 2025 |
| K243927 — MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG May 16, 2025 |
| K242569 — Mixed Reality Spine Navigation | Brainlab AG May 16, 2025 |
| K250099 — Mobius3D (4.1) | Varian Medical Systems May 16, 2025 |
| K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics May 15, 2025 |