| K251133 — AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. May 8, 2025 |
| K233271 — OsseOne Dental Implant System | Synoross Dba Osseone May 8, 2025 |
| K251128 — Extremity Medical External Fixation System | Extremity Medical, LLC May 7, 2025 |
| K251111 — Cary | Excitus AS May 7, 2025 |
| K243684 — BrightHeart View Classifier | Brightheart May 7, 2025 |
| K250222 — SDF Pro | Belport Company, Inc., Gingi-Pak May 7, 2025 |
| K242975 — Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. May 7, 2025 |
| K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific May 7, 2025 |
| K241980 — !M1 | Solutions For Tomorrow AB May 6, 2025 |
| K250785 — Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. May 6, 2025 |
| K251094 — Alma Veil | Wontech Co., Ltd. May 6, 2025 |
| K250160 — ANKYRAS | Mentice Spain S.L. May 6, 2025 |
| K243017 — IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) | Foshan Newface Electronic Technology Co., Ltd. May 6, 2025 |
| K250253 — IPL Hair Removal Device (KCA511/KCA516/KCA522) | Dongguan Boyuan Intelligent Technology Co.,Ltd May 6, 2025 |
| K240447 — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions, LLC May 5, 2025 |
| K242386 — Bluemoon | Genoss Co., Ltd. May 5, 2025 |
| K243603 — AeviceMD | Aevice Health Pte. , Ltd. May 5, 2025 |
| K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. May 5, 2025 |
| K242962 — Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH May 5, 2025 |
| K250728 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. May 5, 2025 |
| K243370 — DentaTOOTH | Asiga Pty, Ltd. May 5, 2025 |
| K242937 — Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) May 5, 2025 |
| K243893 — Second Opinion® Pediatric | Pearl, Inc. May 5, 2025 |
| K251071 — Fetal EchoScan (v1.1) | Brightheart May 2, 2025 |
| K243894 — F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. May 2, 2025 |
| K242986 — SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. May 2, 2025 |
| K250629 — Sutil Rich Personal Lubricant | Hathor Professional Skincare , Ltd. May 2, 2025 |
| K243069 — LUMYS (V1) | Intradys May 2, 2025 |
| K243828 — CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. May 2, 2025 |
| K242583 — AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. May 2, 2025 |
| K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. May 2, 2025 |
| K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation May 2, 2025 |
| K242763 — JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. May 2, 2025 |
| K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | Karl Storz SE & CO. KG May 2, 2025 |
| K251056 — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. May 2, 2025 |
| K243757 — Shockwave CS Guide Catheter | Shockwave Medical, Inc. May 2, 2025 |
| K243114 — SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. May 2, 2025 |
| K243043 — Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. May 2, 2025 |
| K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point Of Care, Inc. May 2, 2025 |
| K250161 — Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | Shenzhen AOJ Medical Technology Co., Ltd. May 2, 2025 |
| K243457 — Nixall Antimicrobial Solutions Skin & Wound Hydrogel | Seriously Clean, Ltd. May 2, 2025 |
| K250995 — Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® May 1, 2025 |
| K242315 — Resolve Modular Revision Hip Stem | United Orthopedic Corporation May 1, 2025 |
| K250087 — Vscan Air | GE Medical Systems Ultrasound And Primary Care Diagnostics May 1, 2025 |
| K251014 — APRO 45 Catheter | Alembic, LLC May 1, 2025 |
| K250029 — ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies May 1, 2025 |
| K250296 — Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. May 1, 2025 |
| K250996 — Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® May 1, 2025 |
| K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | Circa Scientific, Inc. May 1, 2025 |
| K250641 — APEX 3D Total Ankle Replacement System | Paragon 28, Inc. May 1, 2025 |