| K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | Wright Medical Technology, Inc. (Stryker Corporation) Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252072 — Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250050 — miDiagnostics HSV-1&2 CSF Test | Midiagnostics NV Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251690 — Arthrex SpeedFLEX Implant | Arthrex, Inc. Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251799 — Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) | Jiangsu Bangbang Intelligent Technology Co., Ltd. Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243270 — TigerConnect Alarm Management | Tigerconnect Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251197 — Dexter L6 System | Distalmotion SA Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252722 — Biopsy Forceps | Fehling Instruments GmbH Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252594 — UltraGuideCTR® image guided soft tissue release system | Sonex Health Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250023 — SMART PCFD | Disior, Ltd. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251104 — SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243833 — Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252054 — SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251334 — NEW DOUBLO 2.0 | Hironic Co., Ltd. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243983 — Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252051 — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252770 — iLet ACE Pump | Beta Bionics, Inc. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252441 — Primero Safe Access System | South53, LLC Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253236 — G-BLOCK | Graphenano Dental S.L. Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH Mon Sep 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252700 — Optima Coil System (Optima Packing Coil System) | Balt USA, LLC Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252105 — Ligence Heart | Ligence Uab Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252221 — Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252435 — Magnetic Surgical System | Levita Magnetics International Corp Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251919 — Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co., Ltd. Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251275 — VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251208 — Tuned Self-Fitting Mobile App | Tuned , Ltd. Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251262 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251204 — FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250318 — Planmed XFI | Planmed OY Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251986 — AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250659 — LoFric Origo | Wellspect AB Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250837 — Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252102 — Alinity m HCV | Abbott Molecular, Inc. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252063 — Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) | Wuhan Dimed Laser Technology Co., Ltd. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252013 — EnSite X EP System | ABBOTT MEDICAL Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251997 — Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251868 — Panther Fusion GI Bacterial Assay | Hologic Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251789 — EMBOTRAP III Revascularization Device | Neuravi Limited Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252371 — uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251791 — Auxano® Wedge Fixation System | Auxano Medical, LLC Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251527 — Brain WMH | Quantib B.V. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251148 — JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251512 — Hi bebe super (BT-150B) | Bistos Co., Ltd. Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |