| K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. Apr 29, 2025 |
| K242255 — Qitexio® 4-Way Stopcock (QIT014) | Medex Apr 29, 2025 |
| K243886 — ExpressCore Biopsy Device | Inrad, Inc. Apr 29, 2025 |
| K250962 — APRO 55 Intermediate Catheter | Alembic, LLC Apr 29, 2025 |
| K242211 — PUMA-G Pediatric System | Coaptech, Inc. Apr 29, 2025 |
| K242951 — Diode laser hair removal machine (QDTM-02) | Beijing Nubway S&T Co., Ltd. Apr 28, 2025 |
| K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | Aventamed Dac Apr 28, 2025 |
| K250958 — APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC Apr 28, 2025 |
| K250977 — Suture-TOOL System | Suturion AB Apr 28, 2025 |
| K243532 — LumiRex Ureteroscope | Contra Healthcare Solutions, LLC Apr 28, 2025 |
| K241663 — Eminent Spine 3D Titanium Pedicle Screw System | Eminent Spine Apr 28, 2025 |
| K243376 — uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. Apr 28, 2025 |
| K243896 — LenSx Laser System (8065998162) | Alcon Laboratories, Inc. Apr 28, 2025 |
| K250158 — Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) | Zhe Jiang Cleisman Industry And Trade Co.,Ltd Apr 28, 2025 |
| K250030 — Flash Ultrasound System 5100 Point of Care | Philips Ultrasound, LLC Apr 28, 2025 |
| K251101 — AIRO Suction Unit (AIRO-01) | Cro, LLC Apr 26, 2025 |
| K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | Sorin Group Italia S.R.L. Apr 25, 2025 |
| K243041 — contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh Apr 25, 2025 |
| K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. Apr 25, 2025 |
| K251117 — Cervical Spine Truss System (CSTS) | 4Web Medical Apr 25, 2025 |
| K243821 — i-Cut | A.M.I. Agency For Medical Innovations GmbH Apr 25, 2025 |
| K243855 — BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. Apr 25, 2025 |
| K243861 — butterflyBVM | Compact Medical, Inc. Apr 25, 2025 |
| K251075 — DYNAMIS Implant System | Promethean Restorative, LLC Apr 25, 2025 |
| K243082 — Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. Apr 25, 2025 |
| K243876 — VERIFY STEAM Integrating Indicator | STERIS Corporation Apr 25, 2025 |
| K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics Apr 25, 2025 |
| K243998 — DCX Disposable Cassette (DCX) | Institut Geroges Lopez Apr 25, 2025 |
| K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. Apr 25, 2025 |
| K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. Apr 25, 2025 |
| K250426 — Amulet Steerable Delivery Sheath | ABBOTT MEDICAL Apr 25, 2025 |
| K250909 — Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. Apr 25, 2025 |
| K250289 — Intracavitary/Interstitial System | Varian Medical Systems Apr 25, 2025 |
| K242321 — Kosmos | EchoNous, Inc. Apr 25, 2025 |
| K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. Apr 25, 2025 |
| K243721 — Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. Apr 25, 2025 |
| K244026 — PAL 7020 Console | Microaire Surgical Instruments, LLC Apr 25, 2025 |
| K250554 — prodisc® L Instruments | Centinel Spine, LLC Apr 25, 2025 |
| K250892 — CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. Apr 25, 2025 |
| K242469 — RFMagik Lite | Agnes Medical Co., Ltd. Apr 25, 2025 |
| K250153 — Neu Platform | Neuhealth Digital , Ltd. Apr 25, 2025 |
| K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., Apr 25, 2025 |
| K243954 — PeriCross Epicardial Access Kit | Circa Scientific, Inc. Apr 24, 2025 |
| K250206 — Diode laser system (Night Universe; Predator) | Ivylaser (Beijing) Technology Co.,Ltd Apr 24, 2025 |
| K250002 — Smart Check O2 (MA0236) | Life Spark Medical, LLC Apr 24, 2025 |
| K242214 — Sonu | Sound Health Systems, Inc. Apr 24, 2025 |
| K250183 — CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. Apr 24, 2025 |
| K243239 — Lung AI (LAI001) | Exo, Inc. Apr 24, 2025 |
| K250262 — GO-PEN® | Go-Pen Aps Apr 24, 2025 |
| K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC Apr 24, 2025 |