| K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. Feb 18, 2025 |
| K243593 — AXS Lift Intracranial Base Catheter | Stryker Neurovascular Feb 18, 2025 |
| K243915 — FIX-C 3D Ti ACIF System | Jeil Medical Corporation Feb 18, 2025 |
| K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Smith & Nephew Medical, Ltd. Feb 18, 2025 |
| K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. Feb 18, 2025 |
| K241737 — Sway System Sports Plus | Sway Medical, Inc. Feb 15, 2025 |
| K243212 — DESS Dental Smart Solutions | Terrats Medical SL Feb 14, 2025 |
| K241527 — Pastelle Pro | Wontech Co., Ltd. Feb 14, 2025 |
| K243294 — Brainomix 360 e-ASPECTS | Brainomix Limited Feb 14, 2025 |
| K250248 — BriefCase-Triage | Aidoc Medical , Ltd. Feb 14, 2025 |
| K242593 — CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Feb 14, 2025 |
| K243696 — AVIEW CAC | Coreline Soft Co., Ltd. Feb 14, 2025 |
| K242776 — LimFlow V-Ceiver | LimFlow, Inc. Feb 14, 2025 |
| K242198 — ICS Dizcovery (1091) | Natus Medical Denmark Aps Feb 14, 2025 |
| K243503 — VIA360 Surgical System | New World Medical, Inc. Feb 14, 2025 |
| K243081 — Green X 21 (PHT-90CHO) | VATECH Co., Ltd. Feb 14, 2025 |
| K241958 — WARD-CSS (v1.2.x) | Ward 24/7 Aps Feb 14, 2025 |
| K241643 — WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. Feb 14, 2025 |
| K241573 — Alinity m Resp-4-Plex | Abbott Molecular, Inc. Feb 14, 2025 |
| K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. Feb 14, 2025 |
| K242104 — Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. Feb 13, 2025 |
| K243319 — Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications Feb 13, 2025 |
| K241410 — EDEN ControlCath | Jmt Co., Ltd. Feb 13, 2025 |
| K241597 — Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. Feb 13, 2025 |
| K243396 — Aptima SARS-CoV-2 Assay | Hologic, Inc. Feb 13, 2025 |
| K241832 — Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | Boston Aesthetics, Inc. Feb 13, 2025 |
| K243912 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Feb 13, 2025 |
| K242317 — Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. Feb 13, 2025 |
| K243778 — Body Temperature Software (BTS) | Fitbit, LLC Feb 13, 2025 |
| K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC Feb 13, 2025 |
| K243546 — AH Plus Endodontic Sealer | Dentsply Sirona, Inc. Feb 13, 2025 |
| K242006 — SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC Feb 12, 2025 |
| K243961 — Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Feb 12, 2025 |
| K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. Feb 12, 2025 |
| K243702 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Feb 12, 2025 |
| K242666 — Fecobionics Anorectal System | Gi Bionics, LLC Feb 12, 2025 |
| K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. Feb 12, 2025 |
| K241418 — OptoMonitor 3 | Opsens, Inc. Feb 12, 2025 |
| K243962 — Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Feb 12, 2025 |
| K243250 — SubtleHD (1.x) | Subtle Medical, Inc. Feb 12, 2025 |
| K243907 — Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. Feb 12, 2025 |
| K243523 — NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. Feb 12, 2025 |
| K241425 — AspenView | Aspen Imaging Healthcare, Inc. Feb 12, 2025 |
| K243188 — CYLOX® ST | Signus Medizintechnik GmbH Feb 11, 2025 |
| K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated Feb 11, 2025 |
| K243155 — Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) | Dongguan Zsr Biomedical Technology Company Limited Feb 11, 2025 |
| K243518 — BinaxNOW COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. Feb 11, 2025 |
| K241634 — Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic And Technology Co., Ltd. Feb 11, 2025 |
| K250200 — InbellaBody System | Inbella Medical, Inc. Feb 11, 2025 |
| K243620 — Vivid iq | GE Medical Systems Ultrasound And Primary Care Diagnostics Feb 11, 2025 |