| Green X 12 SE (PHT-40CHS) (K243088) | VATECH Co., Ltd. | 2025-02-21 |
| 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)) (K243115) | Shenzhen Urion Technology Co., Ltd. | 2025-02-21 |
| ScanDiags Ortho L-Spine MR-Q (K242607) | Scandiags AG | 2025-02-21 |
| Primus Spinal Fixation System (K243916) | Spinal Elements, Inc. | 2025-02-21 |
| LYMA Laser PRO (K243330) | Lyma Life , Ltd. | 2025-02-21 |
| Wearable breast pump (model W8) (K242850) | Shenzhen TPH Technology Co., Ltd. | 2025-02-21 |
| Xpert® FII & FV (K250218) | Cepheid | 2025-02-21 |
| Powered Mobility Scooter (K250027) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-02-21 |
| VITA YZ Multi Translucent (K243940) | Vita Zahnfabrik H.Rauter GmbH & Co. | 2025-02-21 |
| Medicom Sterilization Pouch and Reel (K243431) | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 |
| QuickRad (K242838) | Aikenist Technologies Pvt, Ltd. | 2025-02-21 |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (K243637) | Materialise NV | 2025-02-21 |
| Sterilization Pouches and Reels (K242898) | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025-02-21 |
| Fassier-Duval Telescoping IM System (K241983) | Orthopediatrics Canada Ulc Dba Pega Medical | 2025-02-21 |
| Custom Abutments (K243278) | Institut Straumann AG | 2025-02-21 |
| TEMP MASTER, PMMA-based dental resin (K243951) | Taiwan Dental Materials Co., Ltd. | 2025-02-21 |
| Extremity Medical External Fixation System (K241563) | Extremity Medical, LLC | 2025-02-21 |
| Paradigm System (K243258) | Proprio, Inc. | 2025-02-21 |
| Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (K243640) | Church & Dwight Co., Inc. | 2025-02-21 |
| SperSort™ Sperm Sorting Chip (IPG02) (K241626) | Ipreg Incorporation | 2025-02-20 |
| CORE Shoulder System (K241470) | LinkBio Corp. | 2025-02-20 |
| CaRi-Plaque (K242240) | Caristo Diagnostics , Ltd. | 2025-02-20 |
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) (K243086) | Unimed Medical Supplies, Inc. | 2025-02-20 |
| 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) (K250214) | Edan Instruments, Inc. | 2025-02-20 |
| Green Card Bowie-Dick Test (BD115) (K250172) | Steritec Products, Inc. (A Getinge Company) | 2025-02-20 |
| Falcon HST (K242447) | Compumedics Limited | 2025-02-20 |
| CER-S (K243312) | Cardiocalm Srl | 2025-02-20 |
| EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (K242821) | Ever Fortune.Ai, Co., Ltd. | 2025-02-20 |
| Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (K243344) | Arthrex, Inc. | 2025-02-20 |
| Defendo Fujifilm 700 Single Use Cleaning Adapter (K250140) | Steris Corparation | 2025-02-20 |
| Medical diode laser systems (CHARISMA, REGAL) (K234004) | Reveal Lasers , Ltd. | 2025-02-20 |
| SparkTM Clear Aligner System (K250487) | Ormco Corporation | 2025-02-20 |
| NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (K242681) | Nurodata, Inc. | 2025-02-20 |
| Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (K250067) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 |
| Phasix ST Umbilical Hernia Patch (K243241) | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 |
| Visby Medical Respiratory Health Test (K242526) | Visby Medical, Inc. | 2025-02-19 |
| Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (K250473) | Dci International, LLC | 2025-02-19 |
| SuperBall-RC™ (K244015) | Arcuro Medical , Ltd. | 2025-02-19 |
| Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) (K241578) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2025-02-19 |
| Brainomix 360 e-Lung (K242411) | Brainomix Limited | 2025-02-19 |
| Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) (K243206) | Sichuan Qianli-Beoka Medical Technology, Inc. | 2025-02-19 |
| A.L.P.S. Small Fragment Plating System (K243761) | Biomet Orthopedics | 2025-02-19 |
| AViTA Pulse Oximeter (SP62B) (K242455) | Avita Corporation | 2025-02-19 |
| EVOS Pelvic and Acetabular System (K241666) | Smith & Nephew | 2025-02-19 |
| Single Use CO2 Laser Fiber (HAF005001) (K243588) | Quanta System Spa | 2025-02-19 |
| Microdent Sterilization Cassette (K242023) | Implant Microdent System S.L.U. | 2025-02-19 |
| Straumann InLab Validated Workflow (K243478) | Institut Straumann AG | 2025-02-19 |
| OPTOVISION Endoscopic Light Source Unit (K243591) | Optosurgical, LLC | 2025-02-19 |
| AXS Lift Intracranial Base Catheter (K243593) | Stryker Neurovascular | 2025-02-18 |
| FIX-C 3D Ti ACIF System (K243915) | Jeil Medical Corporation | 2025-02-18 |
| RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port (K243576) | Smith & Nephew Medical, Ltd. | 2025-02-18 |
| 0.04 ZERO ZERO FOUR Male Latex Condom (K243584) | Okamoto USA, Inc. | 2025-02-18 |
| Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (K243574) | Microport Orthopedics, Inc. | 2025-02-18 |
| Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) (K243792) | Basic Medical Technology, Inc. | 2025-02-18 |
| Sway System Sports Plus (K241737) | Sway Medical, Inc. | 2025-02-15 |
| DESS Dental Smart Solutions (K243212) | Terrats Medical SL | 2025-02-14 |
| Pastelle Pro (K241527) | Wontech Co., Ltd. | 2025-02-14 |
| BriefCase-Triage (K250248) | Aidoc Medical , Ltd. | 2025-02-14 |
| LimFlow V-Ceiver (K242776) | LimFlow, Inc. | 2025-02-14 |
| WARD-CSS (v1.2.x) (K241958) | Ward 24/7 Aps | 2025-02-14 |
| WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (K241643) | Wontech Co., Ltd. | 2025-02-14 |
| Alinity m Resp-4-Plex (K241573) | Abbott Molecular, Inc. | 2025-02-14 |
| ICS Dizcovery (1091) (K242198) | Natus Medical Denmark Aps | 2025-02-14 |
| VIA360™ Surgical System (K243503) | New World Medical, Inc. | 2025-02-14 |
| Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) (K243136) | Shenzhen Finicare Co., Ltd. | 2025-02-14 |
| AVIEW CAC (K243696) | Coreline Soft Co., Ltd. | 2025-02-14 |
| Brainomix 360 e-ASPECTS (K243294) | Brainomix Limited | 2025-02-14 |
| Green X 21 (PHT-90CHO) (K243081) | VATECH Co., Ltd. | 2025-02-14 |
| CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (K242593) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-02-14 |
| Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (K241832) | Boston Aesthetics, Inc. | 2025-02-13 |
| Ampa One System (AMPA-001) (K243319) | Neuromodulatory Devices & Applications | 2025-02-13 |
| Newclip Patient-matched instrumentation non sterile PSI (K243912) | Newclip Technics | 2025-02-13 |
| EDEN ControlCath (K241410) | Jmt Co., Ltd. | 2025-02-13 |
| Integrated Endo System (Meet Endo-II) (K242317) | Denjoy Dental Co., Ltd. | 2025-02-13 |
| FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (K250117) | Assure Tech., LLC | 2025-02-13 |
| Body Temperature Software (BTS) (K243778) | Fitbit, LLC | 2025-02-13 |
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Penumbra System (Reperfusion Catheter RED 72) (K242104) | Penumbra, Inc. | 2025-02-13 |
| AH Plus Endodontic Sealer (K243546) | Dentsply Sirona, Inc. | 2025-02-13 |
| Freedom® Total Knee System - Porous Tibial Base Plate (K241597) | Maxx Orthopedics, Inc. | 2025-02-13 |
| Electrically Powered Wheelchair (K243961) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-02-12 |
| NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (K243523) | Siemens Medical Solutions USA, Inc. | 2025-02-12 |
| Affixus Tibial Nailing System - 4mm screws (K243907) | Zimmer, Inc. | 2025-02-12 |
| OptoMonitor 3 (K241418) | Opsens, Inc. | 2025-02-12 |
| ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575) | Biokit, S.A. | 2025-02-12 |
| SureWave Elastography (Q7000225) (K242006) | Quality Electrodynamics, LLC | 2025-02-12 |
| SubtleHD (1.x) (K243250) | Subtle Medical, Inc. | 2025-02-12 |
| Etiometry Platform (DAV 5.4 RAE 9.2) (K241479) | Etiometry, Inc. | 2025-02-12 |
| AspenView (K241425) | Aspen Imaging Healthcare, Inc. | 2025-02-12 |
| Electrically Powered Wheelchair (K243962) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-02-12 |
| Fecobionics Anorectal System (K242666) | Gi Bionics, LLC | 2025-02-12 |
| V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System (K243702) | Samsung Medison Co., Ltd. | 2025-02-12 |
| BinaxNOW™ COVID-19 Antigen Self Test (K243518) | Abbott Diagnostics Scarborough, Inc. | 2025-02-11 |
| Vivid iq (K243620) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-02-11 |
| MOR (K241897) | Morari, Inc. | 2025-02-11 |
| CYLOX® ST (K243188) | Signus Medizintechnik GmbH | 2025-02-11 |
| NUVENTUS NV.C™ Surgical Cassette and Tray (K243317) | Infinitum Eta, Ltd. | 2025-02-11 |
| InbellaBody System (K250200) | Inbella Medical, Inc. | 2025-02-11 |
| Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) (K241634) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-11 |