| AI-Rad Companion Prostate MR (K252608) | Siemens Healthcare GmbH | 2025-09-09 |
| MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test (K251040) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 |
| Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) (K251773) | Shenzhen Yongquan Medical Devices Co., Ltd. | 2025-09-09 |
| MuscleView 2.0 (K251682) | Springbok, Inc. (Dba Springbok Analytics) | 2025-09-09 |
| AquaA (K252181) | Fresenius Medical Care North America | 2025-09-09 |
| PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (K250483) | Stryker Instruments | 2025-09-09 |
| Hybrid Viewer (00859873006240) (K252477) | Hermes Medical Solutions AB | 2025-09-09 |
| Electric Wheelchair (GY-E001) (K251891) | Shandong Guyue Healthcare Appliance Co., Ltd. | 2025-09-09 |
| qER-CTA (v1.0) (K251610) | Qure.Ai Technologies | 2025-09-08 |
| DUO Microcatheter (K250960) | Rev Neuro, LLC | 2025-09-08 |
| Coaptium Connect with Tissium Light (K251957) | Tissium SA | 2025-09-08 |
| BioTraceIO Vision (V1.7) (K251931) | Techsomed Medical Technologies | 2025-09-08 |
| Dual Action Tissue Closure Device (K250229) | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 |
| MAXXOS P.A.C.E. Foot & Ankle Plating System (K251892) | Maxxos Medical GmbH | 2025-09-08 |
| Wearable Breast Pump (Model S33) (K251754) | Shenzhen TPH Technology Co., Ltd. | 2025-09-08 |
| Momcozy Wearable Breast Pump (BP223) (K251394) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-09-08 |
| OmniTom Elite with PCD (K250928) | Neurologica Corporation | 2025-09-08 |
| da Vinci Surgical System (IS5000) (K251227) | Intuitive Surgical, Inc. | 2025-09-08 |
| GenaCheck COVID-19 Rapid Self-Test (K251753) | Genabio Diagnostics, Inc. | 2025-09-05 |
| High Pressure Tubing (K244038) | Shandong Int Medical Instruments Co., Ltd. | 2025-09-05 |
| 3D-SHAPER (K251022) | 3D-Shaper Medical S.L | 2025-09-05 |
| pREBOA-PRO Catheter (K243795) | Prytime Medical Devices, Inc. | 2025-09-05 |
| Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (K252478) | Bard Access Systems, Inc. | 2025-09-05 |
| Ureteral Access Sheath (K250132) | Zhejiang YiGao Medical Technology Co., Ltd. | 2025-09-05 |
| Ion Endoluminal System (IF1000) (K252528) | Intuitive Surgical, Inc. | 2025-09-05 |
| All-Suture Dual Anchor System (K250095) | Suturetech, Inc. | 2025-09-05 |
| ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) (K251250) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-05 |
| The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (K250575) | Thermo Fisher Scientific | 2025-09-05 |
| WatchPAT400 (WP400) (K250460) | Itamar Medical , Ltd. | 2025-09-05 |
| SOLOPASS 2.0 System (K251317) | Intravent Medical Partners | 2025-09-05 |
| Rapid Obstructive Hydrocephalus, Rapid OH (K251533) | Ischemaview, Inc. | 2025-09-04 |
| Symani Surgical System (K251510) | Medical Microinstruments, Inc. | 2025-09-04 |
| Optina-4C (MHRC-C1N) (K250770) | Optina Diagnostics, Inc. | 2025-09-04 |
| Oniris; Oniris Plus (K250353) | Oniris | 2025-09-04 |
| KALA MINI 2.0 (KALA-04) (K251781) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-09-04 |
| LIBERTY Endovascular Robotic System (LIBERTYOS) (K243789) | Microbot Medical , Ltd. | 2025-09-04 |
| Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (K251438) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 |
| Image Suite (K251168) | Carestream Health, Inc. | 2025-09-04 |
| Endoskeleton™ Interbody Systems (K251444) | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 |
| Fluido® AirGuard System (K251733) | The Surgical Company International BV (As Tsc Life) | 2025-09-04 |
| EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (K251463) | ABBOTT MEDICAL | 2025-09-04 |
| Ball Joint Guide Array (66295) (K250893) | Bayer Medical Care, Inc. | 2025-09-04 |
| Dose+ (1.0) (K250064) | Mvision AI OY | 2025-09-04 |
| Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (K251298) | Clinical Laserthermia Systems, AB | 2025-09-04 |
| Apollo TMS Therapy System (K243700) | Mag & More GmbH | 2025-09-04 |
| Intense Pulsed Light Therapy Device (MMABM-1) (K251545) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025-09-04 |
| NextAR(TM) Shoulder Platform (K251737) | Medacta International S.A. | 2025-09-04 |
| Careverse CoronaryDoc (Careverse CoronaryDoc) (K251656) | Careverse Technology Pte. , Ltd. | 2025-09-04 |
| Kinos Total Ankle System (K252454) | Restor3D | 2025-09-03 |
| NeurotriS (SX2500); NeurotriS (SX3800) (K251909) | A-1 Engineering | 2025-09-03 |
| AquaCast Mask (K252174) | Blessing Cathay Corporation | 2025-09-03 |
| Diode laser therapy device (VADER) (K251457) | Beijing Superlaser Technology Co., Ltd. | 2025-09-03 |
| Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) (K250231) | Dongguan E-Test Technology Co., Ltd. | 2025-09-03 |
| BruxZir® NOW (K252446) | Prismatik Dentalcraft, Inc. | 2025-09-03 |
| Tempus Pixel (K252539) | Arterys, Inc. | 2025-09-03 |
| AGNES Ultra (K250217) | Agnes Medical Co., Ltd. | 2025-09-03 |
| MEDILIGHT (K231952) | Medicreations, LLC | 2025-09-03 |
| SignalNED System (Model RE) (K251726) | Forest Devices, Inc. | 2025-09-03 |
| AViTA Arm Type Blood Pressure Monitor Cuff (K250765) | Avita Corporation | 2025-09-03 |
| IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (K251575) | Alphatec Spine | 2025-09-03 |
| VELMENI for DENTISTS (V4D) (K250753) | Velmeni, Inc. | 2025-09-02 |
| Aerogen Pro-X1 Controller System (K251615) | Aerogen, Ltd. | 2025-09-02 |
| IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) (K250453) | Philips Medizin Systeme Böblingen GmbH | 2025-09-02 |
| Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (K251975) | Ignite Orthomotion | 2025-09-02 |
| OsteoSight™ Hip (v1) (K251408) | Naitive Technologies, Ltd. | 2025-09-02 |
| RODIN Cement (K251775) | Belport Company, Inc., Gingi-Pak | 2025-09-02 |
| Customized Abutment and Screw (K242768) | Chengdu Besmile Medical Technology Co., Ltd. | 2025-09-02 |
| Erbe ESU Model VIO® 3n with Accessories (K251108) | Erbe Elektromedizin GmbH | 2025-08-29 |
| Fetal Pillow (K243799) | CooperSurgical, Inc. | 2025-08-29 |
| CurvaFix Low Profile System (K252019) | Curvafix, Inc. | 2025-08-29 |
| Invisalign System (K252380) | Align Technology, Inc. | 2025-08-29 |
| ArTT Augments and Buttresses and Bone Screws (K251718) | Lima Corporate S.P.A. | 2025-08-29 |
| G aenial Universal Injectable II (K251946) | GC America, Inc. | 2025-08-29 |
| PV01 PVDF Effort Sensor (K251480) | Neurotronics, LLC | 2025-08-29 |
| SurgiTwin (K250290) | Twinsight | 2025-08-29 |
| Edwards eSheath Optima introducer set (K252364) | Edwards Lifesciences | 2025-08-29 |
| Sunrise (K250874) | Sunrise SA | 2025-08-29 |
| GLAM LED Facial Mask (TB-2386F) (K251727) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2025-08-29 |
| GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (K250003) | Geneseeq Technology, Inc. | 2025-08-29 |
| Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392) | Perfuze, Ltd. | 2025-08-29 |
| Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) (K251181) | Merit Medical Ireland, Ltd. | 2025-08-29 |
| FG Bone Graft B (K243745) | Full Golden Biotech Corporation | 2025-08-29 |
| PRAEVAorta®2 (K243859) | Nurea | 2025-08-29 |
| SmartGuard technology; Predictive Low Glucose technology (K251217) | Medtronic Minimed, Inc. | 2025-08-29 |
| Primescan 2 (K250771) | Dentsply Sirona, Inc. | 2025-08-29 |
| Regenesis EMS Chair (K251026) | Trinity Medical Solutions | 2025-08-29 |
| NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL (K250285) | Raumedic AG | 2025-08-29 |
| da Vinci SP Surgical System (SP1098) (K251324) | Intuitive Surgical, Inc. | 2025-08-29 |
| SIRIUS Endoscope System (PR-SI-1230) (K250939) | Precision Robotics (Hong Kong) Limited | 2025-08-29 |
| IVA & AEON Cervical and Lumbar Cage System (K250335) | K&J Consulting | 2025-08-29 |
| EZ™ IV Administration Set (K251814) | Epic Medical Pte. , Ltd. | 2025-08-29 |
| Sonosite LX and Sonosite PX Ultrasound Systems (K251106) | FUJIFILM Sonosite, Inc. | 2025-08-29 |
| da Vinci SP Firefly Imaging System (K252350) | Intuitive Surgical, Inc. | 2025-08-28 |
| SV600, SV800 Ventilator (K243767) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014) | Thermo Fisher Scientific | 2025-08-28 |
| RadiForce GX570; RadiForce GX570-AR (K252030) | Eizo Corporation | 2025-08-28 |
| Somfit D (K252383) | Compumedics Limited | 2025-08-28 |
| OTC 4-Channel Rechargeable TENS Unit (K251429) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-08-28 |
| Powder-Free Vinyl Exam Gloves, clear (K252505) | Basic Medical Technology, Inc. | 2025-08-28 |
| Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (K252057) | Imperative Care, Inc. | 2025-08-28 |