| K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261549 — BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260864 — Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261621 — TekBrace Solo Soft Tissue Reinforcement Device | Theramicro Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260748 — ES-Series | E-Scopics Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251944 — Lipocosm Harmonic System | Lipocosm, LLC Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253542 — Apollo Quattro (APQ-10M) | Weero Co., Ltd. Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253257 — Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260332 — EchoNext | Pathwai, Inc. Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261402 — Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253066 — ELEOS with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261352 — 2D Hip Planning Software | One Ortho Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254086 — EyeBOX SNAP | Oculogica, Inc. Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260289 — Perfect-O Ostial Positioning Catheter | Balosmark, Inc. Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253162 — Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253296 — Digital C-ARM with 3D | Allengers Medical Systems Limited Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260301 — Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251684 — Alma TED+ System | Alma Lasers, Inc. Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253656 — OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261492 — FieldFlex Steerable Sheath | CenterPoint Systems, LLC Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253204 — Catalyze | BioTissue Holdings, Inc. Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253108 — VEOFIX Snap Off Screw | Steps Ortho Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260761 — APTUS Clavicle System 2.8 | Medartis AG Fri Jun 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254209 — Radius VSM and Accessories | Masimo Corporation Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260690 — LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253102 — GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253893 — Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253602 — Precision S 4K Sinuscope | Stryker Endoscopy Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253004 — LUNA 3D | Lap GmbH Laser Applikationen Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261519 — Sonio Suspect | Sonio Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253553 — Orion | Resmed Corp Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260956 — Spectra Platinum Mini | Uzinmedicare Co., Ltd. Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253020 — Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261510 — Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253984 — Instrument Exit Point on Touch Surgery Aide | Covidien, LLC Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253026 — Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253994 — TroKit Laparoscope Lens Wiper | TroCare, LLC Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260662 — Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260497 — DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. Thu Jun 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261530 — iiSure Infusion Set | Deka Research and Development Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261439 — Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253974 — Roosin Collagen Dressing | Roosin Medical Co., Ltd. Wed Jun 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |