| K254249 — HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253778 — Allday Moisturizing Rinse | Elevate Oral Care Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252448 — AViTA Pulse Oximeter (SP61) | Avita Corporation Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253829 — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253536 — Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253797 — One-Stop | Mediclus Co., Ltd. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. Fri Feb 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254017 — SWINGO-3D Lumbar Cage System | Implanet Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260254 — Enbio PRO | Enbio Group AG Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252166 — RIB LINK Fixation System | Globus Medical, Inc. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253328 — GMK 3D Metal Tibial Tray Extension | Medacta International S.A. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254182 — Aster | Osteonic Co., Ltd. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253641 — Owl Night Guard | Owl Dental Lab, Inc. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251860 — Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm | Speciality Fibres and Materials Limited Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253791 — PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254251 — InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253578 — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254271 — CAPRI | ORO Co., Ltd. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253021 — ANNE Maternal | Sibel Health, Inc. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253764 — ENOS Software Guided External Fixation System | Disior, Ltd. Thu Feb 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260222 — Mako Total Knee Application | Mako Surgical Corp. Wed Feb 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251724 — Remi Impression Material | Grindguard, Inc. Wed Feb 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253996 — BD Surgiphor Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) Wed Feb 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253559 — Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. Wed Feb 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253472 — FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical Wed Feb 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253789 — Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. Wed Feb 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251687 — Konig Bell Circumcision Clamp | Medline Industries, LP Wed Feb 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251678 — Swift Ray 1 | Swift Medical, Inc. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253978 — Universal Seal (5-12 mm) | Intuitive Surgical, Inc. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252599 — Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics , Ltd. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254247 — OSTEOMNI SPINAL FIXATION SYSTEM | Osteomni, Inc. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253186 — HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254055 — OSSIOfiber® Suture Anchor | OSSIO , Ltd. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260287 — SP Electrocautery Device (SP20) | Single Pass, Inc. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260217 — AI Platform 2.2 (AIP002) | Exo Imaging Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253714 — IntraSight Plus | Philips Image Guided Therapy Corporation Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253707 — Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260377 — XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254267 — NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252795 — ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | Argon Medical Devices, Inc. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253666 — IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253486 — SKIA-Head (Model: SKIA-ST00) | Skia, Inc. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253068 — Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253631 — Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253583 — LUX Expandable Lumbar Interbody System | Xenix Medical Mon Feb 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |