| K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243115 — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243916 — Primus Spinal Fixation System | Spinal Elements, Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243940 — VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242850 — Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250218 — Xpert® FII & FV | Cepheid Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243614 — Sonio Suspect | Sonio Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243431 — Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241983 — Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242898 — Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241563 — Extremity Medical External Fixation System | Extremity Medical, LLC Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241186 — Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243258 — Paradigm System | Proprio, Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243951 — TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242838 — QuickRad | Aikenist Technologies Pvt, Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243278 — Custom Abutments | Institut Straumann AG Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243088 — Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243330 — LYMA Laser PRO | Lyma Life , Ltd. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | Rti Surgical, Inc. Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234004 — Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers , Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242681 — NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) | Nurodata, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Edan Instruments, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243283 — Alinity h-series System | Abbott Laboratories Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243312 — CER-S | Cardiocalm Srl Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242240 — CaRi-Plaque | Caristo Diagnostics , Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242447 — Falcon HST | Compumedics Limited Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241626 — SperSort Sperm Sorting Chip (IPG02) | Ipreg Incorporation Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250487 — SparkTM Clear Aligner System | Ormco Corporation Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241470 — CORE Shoulder System | LinkBio Corp. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243086 — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | Unimed Medical Supplies, Inc. Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250172 — Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation Thu Feb 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243761 — A.L.P.S. Small Fragment Plating System | Biomet Orthopedics Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242455 — AViTA Pulse Oximeter (SP62B) | Avita Corporation Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243241 — Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241666 — EVOS Pelvic and Acetabular System | Smith & Nephew Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243588 — Single Use CO2 Laser Fiber (HAF005001) | Quanta System Spa Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241578 — Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242526 — Visby Medical Respiratory Health Test | Visby Medical, Inc. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242023 — Microdent Sterilization Cassette | Implant Microdent System S.L.U. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243478 — Straumann InLab Validated Workflow | Institut Straumann AG Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244015 — SuperBall-RC | Arcuro Medical , Ltd. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242411 — Brainomix 360 e-Lung | Brainomix Limited Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243591 — OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243206 — Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) | Sichuan Qianli-Beoka Medical Technology, Inc. Wed Feb 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |