| K241597 — Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. Feb 13, 2025 |
| K243912 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Feb 13, 2025 |
| K243319 — Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications Feb 13, 2025 |
| K243778 — Body Temperature Software (BTS) | Fitbit, LLC 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 |
| K243546 — AH Plus Endodontic Sealer | Dentsply Sirona, Inc. Feb 13, 2025 |
| K243396 — Aptima SARS-CoV-2 Assay | Hologic, Inc. Feb 13, 2025 |
| K241410 — EDEN ControlCath | Jmt Co., Ltd. Feb 13, 2025 |
| K242317 — Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. Feb 13, 2025 |
| K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. Feb 12, 2025 |
| K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. Feb 12, 2025 |
| K241425 — AspenView | Aspen Imaging Healthcare, Inc. Feb 12, 2025 |
| K243907 — Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. Feb 12, 2025 |
| K243961 — Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. 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 |
| K243250 — SubtleHD (1.x) | Subtle Medical, Inc. Feb 12, 2025 |
| K242006 — SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC Feb 12, 2025 |
| K243962 — Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Feb 12, 2025 |
| K242666 — Fecobionics Anorectal System | Gi Bionics, LLC Feb 12, 2025 |
| K241418 — OptoMonitor 3 | Opsens, Inc. Feb 12, 2025 |
| K243523 — NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. Feb 12, 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 |
| K243188 — CYLOX® ST | Signus Medizintechnik GmbH Feb 11, 2025 |
| K241634 — Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic And Technology Co., Ltd. Feb 11, 2025 |
| K243518 — BinaxNOW COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. Feb 11, 2025 |
| K241462 — LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. Feb 11, 2025 |
| K243317 — NUVENTUS NV.C Surgical Cassette and Tray | Infinitum Eta, Ltd. Feb 11, 2025 |
| K241897 — MOR | Morari, Inc. Feb 11, 2025 |
| K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated Feb 11, 2025 |
| K243628 — Vivid T9/Vivid T8 | GE Medical Systems Ultrasound And Primary Care Diagnostics Feb 11, 2025 |
| K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Roche Molecular Systems, Inc. Feb 11, 2025 |
| K241817 — InSet Total Shoulder System | Shoulder Innovations, Inc. 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 |
| K243201 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific Feb 10, 2025 |
| K241516 — BTL-398 | BTL Industries, Inc. Feb 10, 2025 |
| K243511 — OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. Feb 10, 2025 |
| K241659 — Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC Feb 10, 2025 |
| K243063 — Myolight Microcurrent Handpiece | Raja Trading Company, Inc. Feb 10, 2025 |
| K240958 — Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. Feb 10, 2025 |
| K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific Feb 10, 2025 |
| K243453 — Philips Lumea IPL | Philips Consumer Lifestyle B.V. Feb 10, 2025 |
| K244042 — Calcium2 | Abbott Ireland Feb 10, 2025 |
| K243516 — Remi Custom Night Guard | Grindguard, Inc. Feb 10, 2025 |
| K242404 — BDC Dental Unit | Bdc Dental Corporation , Ltd. Feb 7, 2025 |
| K242713 — Any-Com Bulk | Mediclus Co., Ltd. Feb 7, 2025 |
| K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine Feb 7, 2025 |
| K241483 — ceramys femoral head system | Encore Medical L.P. Feb 7, 2025 |
| K242368 — Symani Surgical System | Medical Microinstruments, Inc. Feb 7, 2025 |
| K243780 — HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. Feb 7, 2025 |