| Multi-Unit DAS System (K243732) | Talladium España, SL | 2026-01-29 |
| UV Smart D60 (K251354) | UV Smart Technologies B.V. | 2026-01-29 |
| Electric Scooter (Mojo-T580) (K252347) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (K253462) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 |
| Electric Scooter (Mojo-T330) (K252349) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| Y-Knotless™ Flex Anchors (K253763) | Conmed Corporation | 2026-01-29 |
| Hand Massager (SM004D) (K251622) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | 2026-01-28 |
| Mpact 3D Metal Implants Extension – DMLS Technology (K251043) | Medacta International S.A. | 2026-01-28 |
| MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (K253224) | ImpediMed Limited | 2026-01-28 |
| NorthStar™ Mapping System (K252164) | Imricor Medical Systems | 2026-01-28 |
| Sleepiz One+ (Model 2.5) (K253388) | Sleepiz AG | 2026-01-28 |
| Seg Pro V3 (RT-300) (K251306) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 |
| Sacroiliac Joint Truss System (SJTS) (K252834) | 4Web Medical | 2026-01-28 |
| Vena MicroAngioscope™ System (K253842) | Vena Medical Holdings Corp | 2026-01-28 |
| HIGHERDOSE Body Sculptor (Model: GS-03) (K252603) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-28 |
| Sterilization Pouch/Roll (K251347) | Sterivic Medical Co., Ltd. | 2026-01-28 |
| Aevumed PROTEKT Suture Anchor (K260004) | Aevumed, Inc. | 2026-01-28 |
| XeliteMed SuperM-Fix Spinal Bone Cement (K251896) | Xelite Biomed , Ltd. | 2026-01-28 |
| FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015) | Koru Medical Systems, Inc. | 2026-01-28 |
| GBT Machine Airflow Prophylaxis Master (K253254) | E.M.S Electro Medical Systems S.A | 2026-01-28 |
| BriefCase-Triage (K251195) | Aidoc Medical , Ltd. | 2026-01-27 |
| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
| InbellaIgnite RF System (K251435) | Inbella Medical, Inc. | 2026-01-27 |
| Optima Coil System (OptiOne Coil System) (K254221) | Balt USA, LLC | 2026-01-27 |
| Reusable 3 Button Fingerswitch Wand (K254220) | Soniquence, LLC | 2026-01-27 |
| MAC 7 Resting ECG Analysis System (K251670) | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 |
| Ascent3T Neonatal Magnetic Resonance Imaging System (K253499) | Eyas Medical Imaging, Inc. | 2026-01-26 |
| Tablo Hemodialysis System (PN-0008000, PN-0006000U) (K253412) | Outset Medical, Inc. | 2026-01-26 |
| Holmium Laser Therapeutic Apparatus (HZ-40) (K253633) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-01-24 |
| Vydence Family of Lasers (K252753) | Vydence Medical Industria E Commercio Ltda | 2026-01-24 |
| LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (K253712) | Shenzhen Rainbow Technology Co., Ltd. | 2026-01-23 |
| Evidence MultiSTAT DOA Urine MultiPlex (K250741) | Randox Laboratories Limited | 2026-01-23 |
| Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (K253748) | Life Spine, Inc. | 2026-01-23 |
| Elitone for Men (K253285) | Elidah, Inc. | 2026-01-23 |
| TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (K253669) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-23 |
| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
| Pneumo Dissector Hook (K252957) | Ab Medica Sas | 2026-01-23 |
| AccuContour 4.0 (K251351) | Manteia Technologies Co., Ltd. | 2026-01-23 |
| HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (K253761) | Devicor Medical Products, Inc. | 2026-01-23 |
| Syntex Exam Gloves (K253160) | Basic Medical Technology, Inc. | 2026-01-23 |
| BodyGuardian Remote Monitoring System (BGRMS v3.0) (K243349) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 |
| POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (K252755) | Point Robotics MedTech, Inc. | 2026-01-23 |
| 3.0T AIR 32CH HNA (K253738) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026-01-23 |
| PhenoMATRIX (K251511) | Copan Wasp Srl | 2026-01-22 |
| AV Vascular (K253735) | Philips Medical Systems Nederland B.V. | 2026-01-22 |
| SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (K252352) | Lima Corporate S.P.A. | 2026-01-22 |
| OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (K252885) | Astura Medical | 2026-01-22 |
| Device 104 Particulate (K251323) | Geistlich Pharma AG | 2026-01-22 |
| Perin Health System (PHD80060-2) (K252984) | Perin Health Devices, LLC | 2026-01-22 |
| IPDmilled Blanks (K253253) | Implant Protesis Dental 2004, S.L. | 2026-01-22 |
| Straumann Variobase Abutments XC for Bridge/Bar (K253315) | Institut Straumann AG | 2026-01-22 |
| Getinge GSS67N Series Steam Sterilizer (K252307) | Maquet GmbH (A Getinge Group Company) | 2026-01-22 |
| Genie MAX Large Bore Introducer Sheath (K253652) | Cultiv8 1, LLC | 2026-01-22 |
| AI-Rad Companion Brain MR (K253057) | Siemens Healthcare GmbH | 2026-01-22 |
| Pump In Style® Pro+ (K253498) | Medela, LLC | 2026-01-22 |
| Boston Pico755 (K252369) | Boston Aesthetics, Inc. | 2026-01-21 |
| Arthrex Variable Angle (VA) Proximal Tibia Plating System (K253713) | Arthrex, Inc. | 2026-01-21 |
| InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) (K251385) | Merit Medical Ireland, Ltd. | 2026-01-21 |
| Affirm 400 (K251286) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2026-01-21 |
| Halcyon, Ethos Radiotherapy System (5.0) (K252977) | Varian Medical Systems, Inc. | 2026-01-21 |
| Nova Max Creat eGFR Monitoring System (K251281) | Nova Biomedical Corporation | 2026-01-21 |
| LumiCera (K260170) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 |
| RoVo Mechanical Thrombectomy System (K253730) | Verge Medical, Inc. | 2026-01-21 |
| Infinity™ OCT System (K254165) | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 |
| VariFuse Adjustable Infusion Catheter (K251318) | Argon Medical Devices, Inc. | 2026-01-20 |
| Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (K253698) | Cooper Surgical | 2026-01-20 |
| Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) (K251338) | Scivita Medical Technology Co., Ltd. | 2026-01-20 |
| Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (K253597) | Canon Medical Systems Corporation | 2026-01-20 |
| Excelsior System (K253291) | Blue Ocean Global | 2026-01-20 |
| Rusch SoftSimplastic Foley Catheters (K252537) | Teleflex Medical Sdn. Bhd. | 2026-01-20 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (K250954) | Carestream Health | 2026-01-20 |
| uCT 780 with uWS-CT-Dual Energy Analysis (K253173) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 |
| Baylis Connector Cable (K254114) | Baylis Medical Technologies, Inc. | 2026-01-18 |
| CARTO™ 3 EP Navigation System V9.0 with PIU Plus (K254085) | Biosense Webster, Inc. | 2026-01-18 |
| NeuroSpan Bridge (K253363) | Auxilium Biotechnologies, Inc. | 2026-01-17 |
| Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970) | Medtronic, Ireland | 2026-01-17 |
| actiTENS mini (K252767) | Sublimed | 2026-01-16 |
| Ion-C (K251714) | SurGenTec, LLC | 2026-01-16 |
| Xpert GI Panel (K251721) | Cepheid | 2026-01-16 |
| Tru Hematology Test (K251249) | Truvian Sciences, Inc. | 2026-01-16 |
| NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg (K252775) | Hycor Biomedical | 2026-01-16 |
| LZI Buprenorphine II Enzyme Immunoassay (K253082) | Lin-Zhi International, Inc. | 2026-01-16 |
| da Vinci Surgical System (IS5000) (K251739) | Intuitive Surgical, Inc. | 2026-01-16 |
| FL-10000U Respiratory Humidifier (K251448) | Flexicare Medical Limited. | 2026-01-16 |
| SeptAlign (K251790) | Spirair, Inc. | 2026-01-16 |
| Azurion R3.1 (K254186) | Philips Medical Systems B.V. | 2026-01-16 |
| Toro 88 Superbore Catheter (K252297) | Toro Neurovascular, Inc. | 2026-01-16 |
| WAVE Clinical Platform (2.0.000) (K250135) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (K253556) | Intuitive Surgical, Inc. | 2026-01-16 |
| VITAL Tubing Sets for Hemodialysis (K251341) | Vital Healthcare Sdn. Bhd. | 2026-01-16 |
| Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (K252205) | Curiteva, Inc. | 2026-01-16 |
| OptoMonitor 3 (K251367) | Opsens, Inc. | 2026-01-16 |
| SOLIUS PRO UVB Light Panel (K252960) | Solius Labs, Inc. | 2026-01-16 |
| Imagine® Enterprise Suite (K252634) | Softlink International Private Limited | 2026-01-16 |
| Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter (K251744) | Medtronic | 2026-01-16 |
| Sana Device (DEN250005) | Sana Health | 2026-01-16 |
| qXR-Detect (K251934) | Qure.Ai Technologies | 2026-01-16 |
| MY01 Continuous Compartmental Pressure Monitor (K251900) | MY01, Inc. | 2026-01-16 |
| CoolTone (K253408) | Zimmer Medizinsysteme GmbH | 2026-01-16 |