| K243661 — Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. Feb 7, 2025 |
| K241453 — Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics Feb 7, 2025 |
| K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. Feb 7, 2025 |
| K242957 — Identify (4.0) | Varian Medical Systems, Inc. Feb 7, 2025 |
| K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC Feb 7, 2025 |
| K242324 — DUTAU-NOVATECH® | Novatech SA Feb 6, 2025 |
| K243784 — Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Feb 6, 2025 |
| K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. Feb 6, 2025 |
| K243465 — Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) | Guangzhou Chuang Zao Mei Technology Co., Ltd. Feb 6, 2025 |
| K250055 — BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. Feb 6, 2025 |
| K244034 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | Ever Global (Vietnam) Enterprise Corporation Feb 6, 2025 |
| K242580 — Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) | Unimed Medical Supplies, Inc. Feb 6, 2025 |
| K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | STERIS Corporation Feb 6, 2025 |
| K241599 — Signature Osteosynthesis Plate System | Signature Orthopaedic Pty , Ltd. Feb 6, 2025 |
| K242192 — Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. Feb 6, 2025 |
| K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Feb 6, 2025 |
| K241702 — CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. Feb 6, 2025 |
| K250061 — Celerity Incubator | STERIS Corporation Feb 6, 2025 |
| K242111 — VIVACE | Unimom.Co Feb 6, 2025 |
| K243817 — Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Feb 6, 2025 |
| K243243 — Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. Feb 6, 2025 |
| K243488 — VMAT PRO | Termosalud Feb 6, 2025 |
| K250066 — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation Feb 6, 2025 |
| K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Guangzhou Decheng Biotechnology Co., Ltd. Feb 6, 2025 |
| K243580 — GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC Feb 5, 2025 |
| K242352 — Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. Feb 5, 2025 |
| K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. Feb 5, 2025 |
| K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav Feb 5, 2025 |
| K242983 — CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. Feb 5, 2025 |
| K242896 — Caliber Intramedullary Fixation System | Nvision Biomedical Technologies Feb 5, 2025 |
| K243790 — GRYPHON X Anchor; HEALIX TRANSTEND Anchor | Depuy Mitek Feb 5, 2025 |
| K241488 — TrainFES Advance | Trainfes Feb 5, 2025 |
| K241593 — BoneMetrics (US) | Gleamer Sas Feb 5, 2025 |
| K243138 — Geon (S2) Nasal Aspirator | Geon Corporation Feb 4, 2025 |
| K243333 — rTOP | Roclub GmbH Feb 4, 2025 |
| K242916 — Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. Feb 4, 2025 |
| K250068 — Venclose digiRF Generator (VCRFG1) | Venclose, Inc. Feb 4, 2025 |
| K241368 — Sonicaid Team3 | Huntleigh Healthcare , Ltd. Feb 3, 2025 |
| K250035 — Contour ProtégéAI+ | Mim Software, Inc. Feb 3, 2025 |
| K241590 — Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | Guangdong Xinyu Electronic And Technology Co., Ltd. Feb 3, 2025 |
| K243268 — TipTraQ (TTQ001) | Pranaq Pte. , Ltd. Feb 3, 2025 |
| K240402 — Cito CBC System | Cytochip, Inc. Feb 3, 2025 |
| K243908 — Tiger 2 System | Zavation Medical Products, LLC Feb 3, 2025 |
| K243146 — iCare APP | Ihealth Labs, Inc. Feb 3, 2025 |
| K241375 — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | Alphatec Spine Feb 3, 2025 |
| K243182 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. Feb 3, 2025 |
| K243393 — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | Shenzhen Ulike Smart Electronics Co., Ltd. Feb 3, 2025 |
| K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | Guangzhou Hehong Biotech Co., Ltd. Feb 3, 2025 |
| K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | Dornier Medtech America Jan 31, 2025 |
| K243742 — Arthrex DynaNite Nitinol Staples | Arthrex, Inc. Jan 31, 2025 |