| Wrinkle Treatment Device (JM1, JM2B) (K244020) | Shenzhen Qianyu Technology Co., Ltd. | 2025-05-01 |
| Xpert Xpress CoV-2/Flu/RSV plus (K250995) | Cepheid® | 2025-05-01 |
| ONE TRAY® Sealed Sterilization Container System (K250029) | Innovative Sterilization Technologies | 2025-05-01 |
| Dentsply Sirona Titanium Bases system (K250295) | Dentsply Sirona | 2025-04-30 |
| Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (K250907) | Sol-Millennium Medical, Inc. | 2025-04-30 |
| UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (K250328) | Canon Medical Systems Corporation | 2025-04-30 |
| AuST Steerable Sheath (K251051) | CenterPoint Systems, LLC | 2025-04-30 |
| Additive Manufacturing (Light Curing) Crown Bridge Resin (K250497) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-30 |
| ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (K250274) | Biomerieux S.A. | 2025-04-30 |
| Resolve Fundus Camera (K250683) | Optain Health, Inc. | 2025-04-30 |
| Stable-L Lumbar Interbody System (K243934) | Nexus Spine, LLC | 2025-04-30 |
| Arctic Sun Stat Temperature Management System (K243942) | Medivance, Inc. | 2025-04-30 |
| APRO 45 Catheter and Alembic Aspiration Tubing (K251015) | Alembic, LLC | 2025-04-30 |
| Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); (K244000) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-30 |
| Persona C HR (K250282) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2025-04-30 |
| LumiRex Bronchoscope (K243541) | Contra Healthcare Solutions, LLC | 2025-04-30 |
| TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024) | Haemonetics | 2025-04-30 |
| 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) (K250308) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-04-29 |
| APRO 55 Intermediate Catheter (K250962) | Alembic, LLC | 2025-04-29 |
| AllNEB (K242354) | Enchant Tek Co. , Ltd. | 2025-04-29 |
| PUMA-G Pediatric System (K242211) | Coaptech, Inc. | 2025-04-29 |
| Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein (K250069) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 |
| LMA Fastrach ETT SU (K242495) | Teleflex Medical | 2025-04-29 |
| Apex Flex (K250617) | Sprintray, Inc. | 2025-04-29 |
| ExpressCore Biopsy Device (K243886) | Inrad, Inc. | 2025-04-29 |
| Qitexio® 4-Way Stopcock (QIT014) (K242255) | Medex | 2025-04-29 |
| Pediatric Plating Platform Hip (K243963) | OrthoPediatrics Corp. | 2025-04-29 |
| APRO 55 Swift Catheter and Alembic Aspiration Tubing (K250958) | Alembic, LLC | 2025-04-28 |
| LumiRex Ureteroscope (K243532) | Contra Healthcare Solutions, LLC | 2025-04-28 |
| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
| Suture-TOOL System (K250977) | Suturion AB | 2025-04-28 |
| Diode laser hair removal machine (QDTM-02) (K242951) | Beijing Nubway S&T Co., Ltd. | 2025-04-28 |
| uAngio AVIVA CX (K243376) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 |
| Eminent Spine 3D Titanium Pedicle Screw System (K241663) | Eminent Spine | 2025-04-28 |
| Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) (K250158) | Zhe Jiang Cleisman Industry and Trade Co.,Ltd | 2025-04-28 |
| Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) (K250256) | Aventamed Dac | 2025-04-28 |
| Flash Ultrasound System 5100 Point of Care (K250030) | Philips Ultrasound, LLC | 2025-04-28 |
| AIRO Suction Unit (AIRO-01) (K251101) | Cro, LLC | 2025-04-26 |
| DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (K243264) | Sorin Group Italia S.R.L. | 2025-04-25 |
| Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (K243570) | Siemens Healthcare Diagnostics | 2025-04-25 |
| butterflyBVM (K243861) | Compact Medical, Inc. | 2025-04-25 |
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (K250046) | Shenzhen Urion Technology Co., Ltd. | 2025-04-25 |
| Amulet™ Steerable Delivery Sheath (K250426) | ABBOTT MEDICAL | 2025-04-25 |
| Self Sealing Sterilization Pouches (K243721) | Wellmed Dental Medical Supply Co., Ltd. | 2025-04-25 |
| i-Cut (K243821) | A.M.I. Agency For Medical Innovations GmbH | 2025-04-25 |
| Infrared Thermometer (K243082) | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 |
| Intracavitary/Interstitial System (K250289) | Varian Medical Systems | 2025-04-25 |
| BD Alaris Infusion System with Guardrails Suite MX (K243855) | Carefusion 303, Inc. | 2025-04-25 |
| RFMagik Lite (K242469) | Agnes Medical Co., Ltd. | 2025-04-25 |
| Prelude Wave Hydrophilic Sheath Introducer (K250909) | Merit Medical Systems, Inc. | 2025-04-25 |
| Kosmos (K242321) | EchoNous, Inc. | 2025-04-25 |
| FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (K250723) | Cardio Flow Inc., | 2025-04-25 |
| PAL 7020 Console (K244026) | Microaire Surgical Instruments, LLC | 2025-04-25 |
| VERIFY STEAM Integrating Indicator (K243876) | STERIS Corporation | 2025-04-25 |
| DYNAMIS™ Implant System (K251075) | Promethean Restorative, LLC | 2025-04-25 |
| Neu Platform (K250153) | Neuhealth Digital , Ltd. | 2025-04-25 |
| DCX Disposable Cassette (DCX) (K243998) | Institut Geroges Lopez | 2025-04-25 |
| cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (K243406) | Roche Molecular Systems, Inc. | 2025-04-25 |
| CastleLoc Pectus Bar System (K250892) | L&K BIOMED Co., Ltd. | 2025-04-25 |
| cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (K243400) | Roche Molecular Systems, Inc. | 2025-04-25 |
| Mako Total Knee Application (3.0); Hybrid Tip Pointer (K250608) | Mako Surgical Corp. | 2025-04-25 |
| Cervical Spine Truss System (CSTS) (K251117) | 4Web Medical | 2025-04-25 |
| contact forte Alpha (K243041) | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 |
| Lung AI (LAI001) (K243239) | Exo, Inc. | 2025-04-24 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K243945) | SurGenTec, LLC | 2025-04-24 |
| PeriCross™ Epicardial Access Kit (K243954) | Circa Scientific, Inc. | 2025-04-24 |
| Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (K242514) | Shenzhen Rogin Medical Co., Ltd. | 2025-04-24 |
| Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) (K250116) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-24 |
| CanMINI Hand and Foot System (K242973) | Canwell Medical Co., Ltd. | 2025-04-24 |
| Diode laser system (Night Universe; Predator) (K250206) | Ivylaser (Beijing) Technology Co.,Ltd | 2025-04-24 |
| CO2 Laser System (CO2 Laser SST-L23) (K250183) | Zhuozhou Summer Star Technologies Co., Ltd. | 2025-04-24 |
| Smart Check O2 (MA0236) (K250002) | Life Spark Medical, LLC | 2025-04-24 |
| Sonu (K242214) | Sound Health Systems, Inc. | 2025-04-24 |
| da Vinci SP Surgical System (SP1098) (K243714) | Intuitive Surgical, Inc. | 2025-04-24 |
| GO-PEN® (K250262) | Go-Pen Aps | 2025-04-24 |
| MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963) | Mentor Worldwide, LLC | 2025-04-24 |
| Freespira Breathing System (K233337) | Freespira, Inc. | 2025-04-24 |
| Electric Nasal Aspirator (BC026, BC025, BC023) (K250697) | Shenzhen Kingboom Technology Co., Ltd. | 2025-04-23 |
| Xpert Knee (K250155) | Newclip Technics | 2025-04-23 |
| EchoGuide (Version 1) (K243479) | Sonavex, Inc. | 2025-04-23 |
| Laon Ortho (K250198) | Laon Medi, Inc. | 2025-04-23 |
| MySpine WebPlanner (K243697) | Medacta International S.A. | 2025-04-23 |
| Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl (K250944) | Gmp Medicare Sdn. Bhd. | 2025-04-23 |
| Dynamis Robotic Surgical System (K243326) | LEM Surgical AG | 2025-04-23 |
| NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz (K242531) | Hycor Biomedical | 2025-04-23 |
| eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) (K250228) | Esonic Technology (Wuhan) Co., Ltd. | 2025-04-23 |
| Parietene™ Macroporous Mesh (PPM5050 ) (K250869) | Sofradim Production | 2025-04-23 |
| Mpact 3D Metal Augments II (K242232) | Medacta International S.A. | 2025-04-23 |
| Annalise Enterprise (K250831) | Annalise-Ai | 2025-04-23 |
| BD CTGCTV2 (K243343) | Bd Integrated Diagnostic Solutions/Becton, | 2025-04-22 |
| Aperta NSE PTA Balloon Dilatation Catheter (K243944) | Goodman Co., Ltd. | 2025-04-22 |
| ARIX Femur Nail System (K242247) | Jeil Medical Corporation | 2025-04-22 |
| Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (K250669) | Medtronic Sofamor Danek USA, Inc. | 2025-04-22 |
| Ventris Intervertebral Body Fusion Device (K243386) | Acuity Surgical Devices, LLC | 2025-04-22 |
| OcuMet Beacon (OCUB100) (K241931) | Ocusciences, Inc. | 2025-04-22 |
| Medentika CAD/CAM Abutments (K242542) | Medentika GmbH | 2025-04-22 |
| Evoblock, Perléon (K243621) | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 |
| Composite Orthodontic Brackets and Buttons (K251196) | Ec Certification Service GmbH | 2025-04-21 |
| D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter (K242254) | Dk Medical Technology Co., Ltd. | 2025-04-21 |