| 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 |
| K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. May 1, 2025 |
| K244020 — Wrinkle Treatment Device (JM1, JM2B) | Shenzhen Qianyu Technology Co., Ltd. May 1, 2025 |
| K243521 — Conical Ti Base abutments | BioHorizons Implant Systems, Inc. May 1, 2025 |
| K250282 — Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.R.L. Apr 30, 2025 |
| K251051 — AuST Steerable Sheath | CenterPoint Systems, LLC Apr 30, 2025 |
| K250295 — Dentsply Sirona Titanium Bases system | Dentsply Sirona Apr 30, 2025 |
| K251015 — APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC Apr 30, 2025 |
| K250328 — UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Canon Medical Systems Corporation Apr 30, 2025 |
| K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. Apr 30, 2025 |
| K250683 — Resolve Fundus Camera | Optain Health, Inc. Apr 30, 2025 |
| K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. Apr 30, 2025 |
| K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Biomerieux S.A. Apr 30, 2025 |
| K243541 — LumiRex Bronchoscope | Contra Healthcare Solutions, LLC Apr 30, 2025 |
| K244000 — Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | Shenzhen AOJ Medical Technology Co., Ltd. Apr 30, 2025 |
| K243934 — Stable-L Lumbar Interbody System | Nexus Spine, LLC Apr 30, 2025 |
| K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Apr 30, 2025 |
| K243942 — Arctic Sun Stat Temperature Management System | Medivance, Inc. Apr 30, 2025 |
| K242354 — AllNEB | Enchant Tek Co. , Ltd. Apr 29, 2025 |
| K243963 — Pediatric Plating Platform Hip | OrthoPediatrics Corp. Apr 29, 2025 |
| K250617 — Apex Flex | Sprintray, Inc. Apr 29, 2025 |
| K250308 — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) | Dongguan Boyuan Intelligent Technology Co.,Ltd Apr 29, 2025 |
| K242495 — LMA Fastrach ETT SU | Teleflex Medical Apr 29, 2025 |