| Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) (K260122) | SteriLance Medical (Suzhou), Inc. | 2026-07-06 |
| Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (K261909) | PCCA, Inc. | 2026-07-06 |
| MobileLink Acetabular Cup System – 40mm ID Inserts (various) (K261009) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| INDIRA CLOUD VIEWER (K261465) | INDIGO TECHNOLOGIES | 2026-07-06 |
| Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) (K261529) | Hartman Medical Group, LLC | 2026-07-06 |
| iTero Lumina™ Pro (K261847) | Align Technology , Ltd. | 2026-07-02 |
| Koios DS (3.8) (K253884) | Koios Medical, Inc. | 2026-07-02 |
| Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825) | Abbott | 2026-07-02 |
| FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (K261880) | Fujifilm Corporation | 2026-07-02 |
| OncoStudio (K260528) | Oncosoft. Inc., | 2026-07-02 |
| Claria System (DEN250034) | Claria Medical, Inc. | 2026-07-02 |
| Insufflation Retention Device (IRD) (11173-325-101) (K261587) | BPEndo, LLC | 2026-07-02 |
| Collagen Wound Powder (K260596) | Ventris Medical | 2026-07-02 |
| FACE4D Aligner (K260527) | Avinent Implant System S.L.U. | 2026-07-02 |
| ILR ECG Analyzer (IM007) (K253463) | Implicity, Inc. | 2026-07-02 |
| Xpert Carba-R (K261867) | Cepheid® | 2026-07-02 |
| OrthoFit (K261129) | Spident Co., Ltd. | 2026-07-02 |
| HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology (K261897) | O&M Halyard, Inc. | 2026-07-02 |
| iPredict-DR (K253704) | iHealthscreen, Inc. | 2026-07-02 |
| SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (K252463) | Edan Instruments, Inc. | 2026-07-02 |
| Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (K252243) | Suzhou Precigenome, Ltd. Co; | 2026-07-02 |
| OptraSCAN System (K260755) | Optrascan, Inc. | 2026-07-02 |
| OSSTM Orthopedic Salvage System (K253434) | Biomet, Inc. | 2026-07-01 |
| Tetric plus Fill;Tetric plus Flow (K261485) | Ivoclar Vivadent, Inc. | 2026-07-01 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253802) | S.M.A.I.O | 2026-07-01 |
| Chromix (K261473) | Termosalud S.L. | 2026-07-01 |
| THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) (K254056) | Olympus Medical Systems Corp. | 2026-07-01 |
| Enteral Syringe (20ml, 60ml) (K252483) | Chirana T.Injecta,A.S. | 2026-07-01 |
| Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (K253420) | SeaSpine Orthopedics Corporation | 2026-07-01 |
| DENTCA Tru Flexible (K261474) | Dentca, Inc. | 2026-07-01 |
| EasyWhip Family (K261021) | Winter Innovations, Inc. | 2026-07-01 |
| Veritas Shoulder System (K260556) | Restor3D | 2026-07-01 |
| OTS Hip (K261852) | Ortoma AB | 2026-07-01 |
| Transcend Bulk Fill Flowable Composite (K262228) | Ultradent Products, Inc. | 2026-07-01 |
| RibPlate System (K261054) | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (K253527) | Covidien, LLC | 2026-07-01 |
| Neodent Implant System - NeoConvert Fit (K261147) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 |
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
| Dandy Ceramic Stain and Glaze (K262195) | Zima International Inc., dba Dandy | 2026-06-30 |
| Ceribell Monitor (K261101) | Ceribell, Inc. | 2026-06-30 |
| ISAAC Neurovascular Navigation Catheter (K261808) | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 |
| UB ERP System (K253767) | Universal Brain | 2026-06-30 |
| NorthStar Mapping System (MAP01 or MAP01-01) (K261119) | Imricor Medical Systems, Inc. | 2026-06-30 |
| MeVis AVM Contour (K260576) | MeVis Medical Solutions AG | 2026-06-30 |
| Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (K261068) | Serpex Medical | 2026-06-30 |
| Zolid Lunaris (K260918) | Amann Girrbach AG | 2026-06-29 |
| Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) (K253628) | Agada Medical, Ltd. | 2026-06-29 |
| LUTRONIC GENIUS (K253484) | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (K261052) | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 |
| Pangea Femur Reconstruction System (K261481) | Stryker GmbH | 2026-06-29 |
| Injectable Root Canal Sealer (KP-Root SP) (K261415) | Guilin Kevin Peter Technology Co., Ltd. | 2026-06-29 |
| Omnipod 6 algorithm (K261461) | Insulet Corporation | 2026-06-29 |
| Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) (K254149) | Sterilmed, Inc. | 2026-06-29 |
| Irrigation Tubing Bipolar Cord Set (K251492) | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| Alturion Series Diagnostic Ultrasound System (K260667) | Philips Ultrasound, LLC | 2026-06-29 |
| ADAS 3D (K253969) | Adas3D Medical S.L. | 2026-06-29 |
| BraiN20® (BraiN20) (K253301) | Time IS Brain, S.L. | 2026-06-27 |
| MIST IC (K261122) | Imagine Milling Technologies, LLC | 2026-06-27 |
| SOMNUM (SOMNUM) (K253390) | Honeynaps Co., Ltd. | 2026-06-27 |
| VERTICALE® Navigation Instruments (K253921) | Silony Medical GmbH | 2026-06-26 |
| Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array (K261442) | Cadwell Industries, Inc. | 2026-06-26 |
| PhAST instrument and PhAST Blood Culture Gram-negative Panel (K253316) | Phast Corp. | 2026-06-26 |
| BioHorizons CEREC Compatible Ti-Bases (K260061) | BioHorizons Implant Systems, Inc. | 2026-06-26 |
| Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) (K261253) | Ziree Co., Ltd. | 2026-06-26 |
| BioTracker 2.0 (K253306) | Biotracker, LLC | 2026-06-26 |
| Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (K250070) | Shenzhen Changkun Technology Co., Ltd. | 2026-06-26 |
| SALGINA 2.5mm Distal Radius System (K261351) | Bonebridge AG | 2026-06-26 |
| Arterial Pressure Monitoring Set/Tray (K261455) | Spectrum Vascular | 2026-06-26 |
| MammoScreen® (5) (K260714) | Therapixel | 2026-06-26 |
| LightningWire Transseptal Puncture System (TPS) (K261745) | ElectroWire Medical | 2026-06-26 |
| ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) (K254232) | Edwards Lifesciences | 2026-06-26 |
| i-STAT Crea cartridge with the i-STAT 1 System (K261039) | Abbott Point of Care, Inc. | 2026-06-26 |
| TENS 7000 Rechargeable 4 Channel (TENS 7000H) (K260412) | Shenzhen Dongdixin Technology Co., Ltd. | 2026-06-26 |
| Arthrex FiberButton (K260018) | Arthrex, Inc. | 2026-06-26 |
| ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) (K260709) | Longeviti Neuro Solutions | 2026-06-25 |
| mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) (K253384) | Seers Technology Co., Ltd. | 2026-06-25 |
| SimplGuide (K261242) | Pendracare | 2026-06-25 |
| UNIQA® Dental Implants System (K251188) | Uniqa Dental, Ltd. | 2026-06-25 |
| Jabra Enhance Select Self-fit (Jabra Enhance Select 550) (K254108) | GN Hearing A/S | 2026-06-25 |
| iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) (K260992) | Neuralytix | 2026-06-25 |
| Wearable breast pump (QY-101, QY-102, QY-108) (K261025) | Shenzhen Qinyi Electronic Technology Co., Ltd. | 2026-06-25 |
| Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) (K252584) | Weyo Surgical Technology , Ltd. | 2026-06-25 |
| ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458) | DePuy Ireland UC | 2026-06-25 |
| VELYS™ Robotic-Assisted Solution (K260480) | Depuy Ireland UC | 2026-06-25 |
| G-Series Grind Guard (K260790) | ASESSO HEALTH, Inc. | 2026-06-25 |
| EliA CTD 13 Screen (K253367) | Phadia AB | 2026-06-25 |
| Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (K260809) | Arthrex, Inc. | 2026-06-25 |
| A5 Anesthesia System (A5); A7 Anesthesia System (A7) (K253330) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-06-25 |
| Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture (K253394) | ETHICON, Inc. | 2026-06-25 |
| IntraOp Alignment System; CONTOUR3D Bending System (K253216) | Alphatec Spine, Inc. | 2026-06-25 |
| syngo.CT Coronary Cockpit (K253786) | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
| DVT Garment (K253386) | Vistar Medical Supplies Co., Ltd. | 2026-06-25 |
| BedDot (G1) (K253274) | Intelligent Dots, LLC | 2026-06-25 |
| MiPACS V5 (1.0.0) (K260231) | Apryse Software Corp | 2026-06-25 |
| Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) (K260937) | Shanghai Waylong Intelligent Technology Co.,Ltd | 2026-06-24 |
| Enhanced Boundary for PCCT (K253560) | Ge Medical Systems, LLC | 2026-06-24 |
| Microdacyn Wound Irrigation Solution (K261023) | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| Target Xtra Detachable Coil (K261772) | Stryker Neurovscular | 2026-06-24 |
| Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 (K253393) | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 |
| CLEAR™ Aspiration System (K253404) | Insera Therapeutics, Inc. | 2026-06-24 |