| XR-Series (XR-10, XR-20) Automated Hematology Analyzers (K253212) | Sysmex America, Inc. | 2026-05-27 |
| RENASYS EDGE (66803126) (K260646) | Smith & Nephew Medical, Ltd. | 2026-05-27 |
| AQUA Laminoplasty Systems (K252930) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| StimelMD (SSMD) system (K260142) | Motion Informatics ltd. | 2026-05-27 |
| Synapse Lung Nodule AI (K254075) | Fujifilm Corporation | 2026-05-27 |
| EPIQ Series Diagnostic Ultrasound System (K260123) | Philips Ultrasound, LLC | 2026-05-27 |
| ResScan Essentials (K254104) | Resmed Corp | 2026-05-27 |
| Dione PEEK Screw System (K253130) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| Glucommander (K254102) | Glytec, LLC | 2026-05-27 |
| LigaPASS™ System (K261374) | Medicrea International S.A.S | 2026-05-27 |
| Helion Viewer Suite (K254265) | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| Visby Medical Flu and COVID-19 Test (K253971) | Visby Medical, Inc. | 2026-05-27 |
| Portable Dental X-ray System Model PDX nova (K260367) | PDX Co., Ltd. | 2026-05-27 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K260680) | Philips Ultrasound, LLC | 2026-05-27 |
| Momcozy Nasal Aspirator (BN007) (K253629) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-26 |
| VIVA combo RF System (K252833) | Starmed Co., Ltd. | 2026-05-26 |
| CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (K254157) | Medos International SARL | 2026-05-26 |
| LOGIQ e (K260398) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-05-26 |
| Digital ClarusScope System and Digital NeuroPEN System (K252790) | Clarus Medical, LLC | 2026-05-26 |
| 4K NIR/ICG Imaging System (K260318) | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 |
| JAZBI™ Resorbable Bone Void Filler (K252797) | Sdip Innovations Pty, Ltd. | 2026-05-26 |
| MediBot Needle Driver Uno (K260183) | Parallel Robotics, LLC | 2026-05-24 |
| Arc Adjustable Radial Cuff Compression Device (K252772) | Tz Medical, Inc. | 2026-05-22 |
| DePuy ATTUNE™ Knee System (K252887) | DePuy Orthopaedics, Inc. | 2026-05-22 |
| Spectrum-2 (K254129) | Neko Health AB | 2026-05-22 |
| PCWP Analysis Software (DEN250057) | Cardiosense, Inc. | 2026-05-22 |
| TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (K261098) | Senzime AB | 2026-05-22 |
| MagVenture Accelerated TMS (aTMS) Therapy System (K260189) | Tonica Elektronik A/S | 2026-05-22 |
| ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (K252917) | Genesee Biomedical, Inc. | 2026-05-22 |
| Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning (K260324) | Canon Medical Informatics, Inc. | 2026-05-22 |
| eXaSkin Plus (K252784) | Anatomical Geometry S.L. | 2026-05-22 |
| Zenith Distal Access Long Sheath (K253359) | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 |
| C-beam (K252735) | Pulmera, Inc. | 2026-05-22 |
| InQwire Amplatz Guide Wire (K254137) | Merit Medical Ireland, Ltd. | 2026-05-22 |
| Atmo Gas Capsule System (K253569) | Atmo Biosciences, Ltd. | 2026-05-22 |
| Ion-C Navigation Instruments (K260329) | SurGenTec, LLC | 2026-05-22 |
| Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong (K253773) | Taizhou Huangyan Guanhong Plastic Steel Products Factory | 2026-05-22 |
| BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (K261280) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 |
| uMR Astra (K260113) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| Sterile Latex Powder Free Surgical Gloves (K253060) | Protect Gloves Company Limited | 2026-05-22 |
| AiSteth® (K252915) | Ai Health Highway India Pvt., Ltd. | 2026-05-22 |
| SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 (K253949) | CHISON Medical Technologies Co., Ltd. | 2026-05-22 |
| Apollo TMS Therapy System;Apollo light TMS Therapy System (K260560) | Mag & More GmbH | 2026-05-22 |
| da Vinci Firefly Imaging System (K260695) | Intuitive Surgical | 2026-05-22 |
| Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask (K251920) | Dcstar, Inc. | 2026-05-21 |
| Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (K261325) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-05-21 |
| Nisus NPWT Canister 500-mL (CPC-500) (K261291) | Cork Medical | 2026-05-21 |
| BAC (K254131) | DeepHealth, Inc. | 2026-05-21 |
| Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (K253112) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| DCMhotbond zircon (K253191) | Dental Creativ Management GmbH | 2026-05-21 |
| Boston 2910 (Boston 2910) (K253245) | Boston Aesthetics, Inc. | 2026-05-21 |
| Ulthera® System (K260618) | Ulthera, Inc. | 2026-05-21 |
| Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K260580) | Olympus Medical Systems Corp. | 2026-05-21 |
| MuCover (proposed name) Oral Wound Dressing (K253816) | MoleculeX Co., Ltd. | 2026-05-21 |
| OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, (K260649) | Olympus Winter & Ibe GmbH | 2026-05-21 |
| PanopticAI Vital Signs (1.6.1-22) (K260066) | PanopticAI Technologies Limited | 2026-05-21 |
| Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses (K253352) | Pegavision Corporation | 2026-05-21 |
| pjur NATURE Touch, 100 ml (K260068) | Pjur Group Luxembourg S.A. | 2026-05-21 |
| Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family (K261315) | Siemens Medical Solutions USA, Inc. | 2026-05-21 |
| ROSA® Shoulder System (K260582) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 |
| Sphincterotome (K260962) | Taewoong Medical Co., Ltd. | 2026-05-21 |
| Wearable Breast Pump (Model S39) (K254244) | Shenzhen TPH Technology Co., Ltd. | 2026-05-21 |
| Stelo Glucose Biosensor System (K261359) | Dexcom, Inc. | 2026-05-21 |
| DeepView AI® System (DEN250028) | Spectralmd, Inc. | 2026-05-21 |
| Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) (K252746) | Drägerwerk AG Co. Kgaa | 2026-05-21 |
| MSK Go (K260234) | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2026-05-21 |
| Manual Wheelchair (DY01903(2)) (K254141) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 |
| ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (K253956) | Sofradim Production | 2026-05-21 |
| uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite (K253720) | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-21 |
| IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) (K260594) | Shenzhen Xiazhifeng Electronic Co., Ltd. | 2026-05-20 |
| WAVE PTA Balloon Catheter (K260304) | WAVE Medical AG | 2026-05-20 |
| Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) | Canon Medical Systems Corporation | 2026-05-20 |
| Derma-2 (K253911) | Neko Health AB | 2026-05-20 |
| Blood Pressure Monitor (W06LT) (K253570) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 |
| MAASTRO Rectal Applicator Set (K252717) | Varian Medical Systems | 2026-05-20 |
| Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (K260351) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026-05-20 |
| LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) (K253134) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
| Elos Accurate® Denture Fixation System (K253774) | Elos Medtech Pinol A/S | 2026-05-20 |
| Mobility Scooter (Air Carbon) (K260717) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-05-20 |
| ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) (K260098) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-20 |
| Zenith Aspiration Catheter; Disposable Aspiration Tubing Set (K252707) | Suzhou Zenith Vascular SciTech Limited | 2026-05-20 |
| The Circadia C300 System (C300) (K261286) | Circadia Health, Inc. | 2026-05-20 |
| Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K261299) | Pegavision Corporation | 2026-05-19 |
| Laport (K252985) | Sejong Medical Co., Ltd. | 2026-05-19 |
| LIAISON PLEX Gastrointestinal Flex Assay (K253722) | Luminex Corporation | 2026-05-19 |
| Taperloc® Complete Hip Stem (K251270) | Biomet, Inc. | 2026-05-19 |
| FilmArray TF Control Panel M527 (K260577) | Maine Molecular Quality Controls, Inc. | 2026-05-19 |
| SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) (K253309) | Shenzhen Soga Technology Co., Ltd. | 2026-05-19 |
| FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146) | Orthofix Srl | 2026-05-19 |
| MR5 Activ Pro (K254024) | Multi Radiance Medical, Inc. | 2026-05-19 |
| DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) (K261071) | DiaDent Group International | 2026-05-19 |
| OrthoEasy Pal; OrthoEasy Pal Long Neck (K260268) | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 2026-05-19 |
| CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (K253831) | Cercare Medical A/S | 2026-05-18 |
| STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (K252047) | ETHICON, Inc. | 2026-05-18 |
| RhinAer+ Stylus (K260522) | Aerin Medical, Inc. | 2026-05-18 |
| HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap (K253454) | O&M Halyard, Inc. | 2026-05-18 |
| G-CEM UNIVERSAL (K254109) | GC America, Inc. | 2026-05-18 |
| Coude Sleeved IC; Coude Plus Sleeved IC (K253295) | Hollister Incorporated | 2026-05-18 |
| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
| BluEX Cervical Expandable Cage System (K260840) | L&K BIOMED Co., Ltd. | 2026-05-16 |