| Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (K260536) | Depuy Ireland UC | 2026-05-15 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) (K260059) | Hycor Biomedical | 2026-05-15 |
| Manual Tissue Removal Device (K254050) | Suzhou AcuVu Medical Technology Co., Ltd. | 2026-05-15 |
| NovaLine Tubing Set for Hemodialysis (BL 124) (K252423) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026-05-15 |
| Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ (K261264) | Bausch and Lomb | 2026-05-15 |
| Varion Thoracolumbar Fixation System (K260989) | Kyocera Medical Technologies Inc. (KMTI) | 2026-05-15 |
| medXion NEXUS (K253935) | medXion Technologies, Inc. | 2026-05-15 |
| NxStage System One with NxView (K252377) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-05-15 |
| SubtleHD-CT (1.x) (K254120) | Subtle Medical, Inc. | 2026-05-15 |
| KARL STORZ Laryngoscopes and Accessories (K252624) | KARL STORZ Endoscopy-America, Inc. | 2026-05-15 |
| Ventana® P/T Lumbar Interbody System (K260506) | Spinal Elements, Inc. | 2026-05-15 |
| Embryo Predict (K250781) | Alife Health | 2026-05-15 |
| Neurophet SCALE PET (K252563) | Neurophet., Inc. | 2026-05-15 |
| uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super (K253716) | Wuhan United Imaging Healthcare Co.,Ltd | 2026-05-15 |
| cobas liat CT/NG/MG nucleic acid test (K253759) | Roche Molecular Systems, Inc. | 2026-05-15 |
| Introcan Safety® Deep Access XL IV Catheter (K253235) | B.Braun Medical, Inc. | 2026-05-15 |
| Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) (K254028) | Sonoscape Medical Corp. | 2026-05-15 |
| Jada System (Jada-2002) (K253642) | Organon, LLC | 2026-05-15 |
| cobas liat CT/NG nucleic acid test (K253756) | Roche Molecular Systems, Inc. | 2026-05-15 |
| UNiD™ Spine Analyzer (SW3002) (K261289) | Medicrea International S.A.S. (Medtronic) | 2026-05-15 |
| TruSelect™ 2.6 Microcatheter (K260771) | Boston Scientific Corporation | 2026-05-15 |
| Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) (K260134) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-15 |
| Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled (K252643) | Teleflex Medical Sdn. Bhd. | 2026-05-15 |
| Neurophet AQUA (K261273) | Neurophet., Inc. | 2026-05-15 |
| MatriDerm (K261224) | Medskin Solutions Dr. Suwelack AG | 2026-05-14 |
| ARIES Anterior Cervical Plate Systems (K252776) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 |
| Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) (K252601) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-05-14 |
| ART.1-US (K253078) | Seetreat Pty, Ltd. | 2026-05-14 |
| ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (K253372) | Hiossen, Inc. | 2026-05-14 |
| BriefCase-Triage (K261317) | Aidoc Medical , Ltd. | 2026-05-14 |
| Dormiva Anti-Snoring Mouth Guard (K261134) | Koncept Innovators, Inc. | 2026-05-14 |
| Palmtop Ultrasound Diagnostic System (MT10P/MT10) (K260111) | Mytech Intelligence (Shenzhen) Co., Ltd. | 2026-05-14 |
| Suction Pump (SU-90) (K260892) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026-05-14 |
| ENTity USB Videoscope System (K254133) | Optim, LLC | 2026-05-14 |
| Bonalive Maxillofacial (K253883) | Bonalive , Ltd. | 2026-05-14 |
| SmartClip Delivery Catheter (ADR-1715) (K260565) | Elucent Medical | 2026-05-14 |
| SubtleHD-PET (1.x) (K254013) | Subtle Medical, Inc. | 2026-05-14 |
| Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) (K254048) | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 |
| TriMed Compression Screws (K261241) | TriMed, Inc. | 2026-05-14 |
| Any-Etch (K260485) | Mediclus Co., Ltd. | 2026-05-14 |
| RAYMO Mobile X-ray System (Model: RAYMO) (K260085) | DRGEM Corporation | 2026-05-14 |
| CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) (K253676) | Providence Medical Technology, Inc. | 2026-05-14 |
| Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr (K252652) | Fortis Biosolutions Company Limited | 2026-05-14 |
| Electric Wheelchair (Y207BL) (K253241) | Jiangsu Intco Medical Products Co., Ltd. | 2026-05-13 |
| SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181) | Surgimage Corporation | 2026-05-13 |
| ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable (K252653) | Acist Medical Systems, Inc. | 2026-05-13 |
| Portable Neuromodulation Stimulator (PoNS) (K253061) | Helius Medical, Inc. | 2026-05-13 |
| Morph (K260032) | BeauBrain Healthcare, Inc. | 2026-05-13 |
| Y-Knotless™ Flex Anchors (K261363) | CONMED Corporation | 2026-05-13 |
| Automatic Micro Needle System (CODE-X) (K252591) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 |
| Electric Breast Pump (HL-3058 II Pro) (K254125) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026-05-13 |
| VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) (K252638) | Acist Medical Systems, Inc. | 2026-05-13 |
| StatSeal Disc (K254073) | Merit Medical Systems, Inc. | 2026-05-13 |
| myLEDmask 2 (MJ-144) (K260415) | Light Tree Ventures Europe B.V. | 2026-05-12 |
| Senhance Ultrasonic System (K254192) | Asensus Surgical | 2026-05-12 |
| Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant (K252731) | Promimic AB | 2026-05-12 |
| BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (K260725) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 |
| CorVision® (91-205-Z0014) (K260051) | CorVent® Medical, Inc. | 2026-05-12 |
| CellDx-Tissue (K260235) | Datar Cancer Genetics Private Limited | 2026-05-12 |
| Promisemed VeriEcto Automatic Biopsy Needles (K261196) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) (K260473) | Shenzhen Kingboom Technology Co., Ltd. | 2026-05-12 |
| Rayvolve (K260378) | AZmed | 2026-05-12 |
| VersaLift Expandable System (K260837) | Life Spine, Inc. | 2026-05-12 |
| OSTEOMNI SPINAL CAGES SYSTEM (K260850) | Osteomni, Inc. | 2026-05-12 |
| Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) (K252655) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-05-11 |
| Dual Core (K260805) | Vericom Co., Ltd. | 2026-05-11 |
| Pytheas Your Guided Trajectory (K252880) | Pytheas Navigation Sas | 2026-05-11 |
| PICO SHINING (PICO-K; PICOFY) (K261214) | Speclipse, Inc. | 2026-05-11 |
| ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) (K260196) | Ethicon Endo-Surgery, LLC | 2026-05-11 |
| Protable Phlegm Suction Unit (JMA D01) (K250964) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2026-05-11 |
| CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) (K253696) | Verathon Medical (Canada) Ulc | 2026-05-11 |
| KARL STORZ Trocars with Valve Seals (K254228) | Karl Storz SE & CO. KG | 2026-05-11 |
| HardyDisk AST Gepotidacin 10µg (GEP10) (K260842) | Hardy Diagnostics | 2026-05-11 |
| Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos (K260846) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-11 |
| Velmeni for Dentists (V4D) Endo-Perio (K252953) | Velmeni, Inc. | 2026-05-11 |
| SAYA 86 Radial Access Guide Catheter (K254178) | Asahi Intecc Co., Ltd. | 2026-05-11 |
| aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (K260385) | Carlsmed, Inc. | 2026-05-09 |
| Avanti Distal Elbow ORIF System (K261145) | Avanti Orthopaedics, LLC | 2026-05-09 |
| Hydro Irrigation System (K253679) | Stryker Instruments | 2026-05-08 |
| Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (K253237) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026-05-08 |
| Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB (K250814) | Zeus Scientific | 2026-05-08 |
| AYON Body Contouring System™ (AYON SYSTEM) (K253396) | Apyx Medical Corporation | 2026-05-08 |
| HipGuide (V 1.0.0.0) (K260321) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| Modius Spero (DEN250013) | Neurovalens Limited | 2026-05-08 |
| Arthrex Beaming System (K254215) | Arthrex, Inc. | 2026-05-08 |
| Disposable Stone Retrieval Balloon Catheter (K253013) | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-05-08 |
| Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991) | Orthofix Srl | 2026-05-08 |
| MiroCam® Capsule Endoscope System (K252617) | Intromedic Co., Ltd. | 2026-05-08 |
| LingOral Dental Design System (K260419) | Hangzhou ChohoTech Co., Ltd. | 2026-05-08 |
| DeepSkin (DEP100) (K252621) | El Global Trade, Ltd. | 2026-05-08 |
| Smylio Aligners (K260788) | Smylio, Inc. | 2026-05-08 |
| AerFrame Patient Immobilization System (AFPIS) (K260792) | Stabilix, LLC | 2026-05-08 |
| Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (K260460) | Institut Straumann AG | 2026-05-07 |
| SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (K253837) | Heidelberg Engineering GmbH | 2026-05-07 |
| SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (K253739) | Globus Medical, Inc. | 2026-05-07 |
| MR Conditional Cup Electrodes (K254183) | Technomed Europe | 2026-05-07 |
| Lynx Aspiration Catheter System (K254276) | Q’Apel Medical, Inc. | 2026-05-07 |
| Evita (V800); Evita (V600) (K253647) | Draegerwerk AG & CO Kgaa | 2026-05-07 |
| Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle (K253826) | Galvanize Therapeutics, Inc. | 2026-05-07 |
| Veritas Reverse Total Shoulder System (K253992) | Restor3D | 2026-05-07 |