| K243665 — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | ZheJiang Decans Medical Devices Co., Ltd. Jan 31, 2025 |
| K242982 — Mobility Scooter (MS160A) | Suzhou Master Machinery Manufacturing Co.,Ltd Jan 31, 2025 |
| K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream | Nanjing Synthgene Medical Technology Co., Ltd. Jan 31, 2025 |
| K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | C.R. Bard, Inc. Jan 31, 2025 |
| K243441 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | Basic Medical Technology, Inc. Jan 31, 2025 |
| K242442 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. Jan 31, 2025 |
| K243150 — Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. Jan 31, 2025 |
| K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps Jan 31, 2025 |
| K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC Jan 31, 2025 |
| K241694 — ZeTTA PACS | Tae Young Soft Co., Ltd. Jan 31, 2025 |
| K241193 — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) | Marzzan Lucas Jorge Jan 31, 2025 |
| K243572 — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | Avanos Medical, Inc. Jan 31, 2025 |
| K243726 — Osprey Suture Anchor | Responsive Arthroscopy, Inc. Jan 30, 2025 |
| K243442 — iBOT® PMD | Mobius Mobility Jan 30, 2025 |
| K242568 — Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. Jan 30, 2025 |
| K242757 — Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. Jan 30, 2025 |
| K243060 — TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. Jan 30, 2025 |
| K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. Jan 30, 2025 |
| K243712 — WasherCap Mini Fixation System (Model 45) | Abanza Tecnomed S.L Jan 30, 2025 |
| K241292 — MyShoulder Planner (5.3SSWPL) | Medacta International S.A. Jan 30, 2025 |
| K233956 — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. Jan 30, 2025 |
| K243025 — Ureteral Access Sheath | Seplou (Zhuhai) Co., Ltd. Jan 30, 2025 |
| K241270 — BTL-754 | BTL Industries, Inc. Jan 30, 2025 |
| K243410 — simpli-COLLECT STI Test | Abbott Molecular Jan 30, 2025 |
| K243202 — MTS Ceftobiprole 0.002-32 µg/mL | Liofilchem S.R.L. Jan 30, 2025 |
| K243673 — Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC Jan 29, 2025 |
| K241915 — CareSuperb COVID-19 Antigen Home Test | Access Bio, Inc. Jan 29, 2025 |
| K243213 — Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. Jan 29, 2025 |
| K243387 — GYDER® Hip System | Gyder Surgical Pty, Ltd. Jan 29, 2025 |
| K242217 — Surcam Dental Implant System | Surcam Medical Devices And Developments, Ltd. Jan 29, 2025 |
| K243117 — Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. Jan 29, 2025 |
| K243740 — Versalock Upper Limb Plating System | GM Dos Reis Industria E Comercio Ltda. Jan 29, 2025 |
| K243042 — Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. Jan 29, 2025 |
| K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company Jan 28, 2025 |
| K244025 — Argo Knotless GENESYS Anchor | Conmed Corporation Jan 28, 2025 |
| K243423 — LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | Shenzhen Rainbow Technology Co., Ltd. Jan 28, 2025 |
| K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG Jan 28, 2025 |
| K243374 — HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. Jan 28, 2025 |
| K243439 — Medical Monitor (27HS714S) | Lg Electronics.Inc Jan 28, 2025 |
| K244027 — SANSA HSAT | Huxley Medical Jan 28, 2025 |
| K231297 — Firstar Dental Unit | Firstar Dental Company Jan 27, 2025 |
| K242941 — CO2 Laser Therapy Systems (SHE-LSP003-1) | Beijing Sano Laser S&T Development Co.,Ltd Jan 27, 2025 |
| K243229 — Bunkerhill AVC | BunkerHill Health Jan 27, 2025 |
| K241266 — Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. Jan 27, 2025 |
| K250014 — Symani Surgical System (820-03830) | Medical Microinstruments, Inc. Jan 27, 2025 |
| K243657 — ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. Jan 24, 2025 |
| K243739 — AxCess® Expandable Interbody System | Elliquence, LLC Jan 24, 2025 |
| K241239 — OrganProtex HTK Solution | Bridge TO Life, Ltd. Jan 24, 2025 |
| K244023 — MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. Jan 24, 2025 |
| K242322 — Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. Jan 24, 2025 |