| REGEN Bioactive Cement (K253337) | Inter-Med, Inc. | 2026-04-15 |
| STERRAD 100NX Sterilization System with ALLClear Technology (10104) (K252843) | Advanced Sterilization Products, Inc. | 2026-04-15 |
| Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (K252404) | Biomet Orthopedics | 2026-04-15 |
| Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (K260129) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-04-15 |
| Midas Restore (K260661) | Sprintray, Inc. | 2026-04-15 |
| VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282) | bioMerieux, Inc. | 2026-04-15 |
| VERIQA RT EPID 3D (K252258) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 |
| IDS-iSYS Total Testosterone (K252728) | Immunodiagnostic Systems Limited | 2026-04-15 |
| BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (K260128) | Becton, Dickinson and Company | 2026-04-15 |
| Refobacin Bone Cement R (110034355) (K254107) | Biomet France | 2026-04-15 |
| ASTar BC G- Kit (K253573) | Q-Linea AB | 2026-04-15 |
| Diode Laser Therapy Systems (V19) (K260307) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
| SureSmile Aligner (ASSY500020) (K260722) | Dentsply Sirona, Inc. | 2026-04-15 |
| PATH BGC (K260938) | Crossroads Neurovascular, Inc. | 2026-04-15 |
| Inbentus Versatile (K252663) | Iconic Solutions by Murcia, SL | 2026-04-14 |
| SPRINT PNS System (K240974) | Spr Therapeutics, Inc. | 2026-04-14 |
| Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) (K253107) | Shenzhen Dongjiang Technology Co., Ltd. | 2026-04-14 |
| Equinoxe® Shoulder System (K260583) | Exactech, Inc. | 2026-04-14 |
| HD 8Ch Wrist Array (K252587) | Shenzhen RF Tech Co., Ltd. | 2026-04-14 |
| Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (K260931) | Unimed Medical Supplies, Inc. | 2026-04-14 |
| TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498) | Corcym S.r.l. | 2026-04-14 |
| Critical Care Suite with Enteric Tube Positioning AI Algorithm (K253502) | Ge Medical Systems, LLC | 2026-04-14 |
| HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES (K260340) | HC Biologics, LLC | 2026-04-13 |
| b-ONE® Bipolar Head (K253357) | B-One Ortho, Corp. | 2026-04-13 |
| HVT 2.0 (K254078) | Vapotherm, Inc. | 2026-04-13 |
| Elecsys Anti-SARS-CoV-2 S (K252280) | Roche Diagnostics | 2026-04-13 |
| CVAC Aspiration System (K260965) | Calyxo, Inc. | 2026-04-13 |
| Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (K253592) | Zimmer, Inc. | 2026-04-13 |
| Heal-Check Rapid COVID-19 Antigen Self-Test (K260095) | Healgen Scientific,, LLC | 2026-04-13 |
| InSet Reverse Total Shoulder System (K254128) | Shoulder Innovations, Inc. | 2026-04-13 |
| Aventus Introducer Sheath (K260091) | Inquis Medical | 2026-04-13 |
| ACORYS MAPPING SYSTEM (K253861) | Corify Care S.L | 2026-04-13 |
| SMART Osteotomy System (K260090) | Actis Medical Pty., Ltd. | 2026-04-10 |
| ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) (K252485) | 1987 Media Limited | 2026-04-10 |
| Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (K252250) | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-10 |
| AI-Rad Companion Organs RT (K252548) | Siemens Healthcare GmbH | 2026-04-10 |
| BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube (K252378) | Becton, Dickinson and Company | 2026-04-10 |
| TRIOS Dx (R1) (K260082) | 3Shape TRIOS A/S | 2026-04-10 |
| Relu Cloud (K252708) | Relu BV | 2026-04-10 |
| Pressio 3 Multi-parameter Neuromonitoring System (K252241) | Sophysa | 2026-04-10 |
| ABL90 FLEX PLUS System, safeCLINITUBES (K252207) | Radiometer Medicals Aps | 2026-04-10 |
| Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads (K253657) | Covidien (Part of Medtronic) | 2026-04-10 |
| Ascblue (8010) (K253777) | Ascblue Corporation | 2026-04-10 |
| Overjet Iris Intelligent Imaging System (K253930) | Overjet, Inc. | 2026-04-10 |
| Diacore (K253926) | ShenB Co., Ltd. | 2026-04-10 |
| ShaeferH (K252942) | Shaeferh, LLC | 2026-04-10 |
| Protaryx Transseptal Puncture Device (PTX2-001) (K260839) | Protaryx Medical, Inc. | 2026-04-10 |
| Porcelain Etch Gel (K260430) | Belport Company, Inc., Gingi-Pak | 2026-04-10 |
| AeroDR TX c02 (K253446) | Dk Medical Systems Co., Ltd. | 2026-04-10 |
| Teleport Glide Microcatheter (K253361) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder (K252506) | Becton, Dickinson and Company | 2026-04-10 |
| CeQur Simplicity™ On-Demand Insulin Delivery System (K252757) | Cequr SA | 2026-04-10 |
| DeepBT Detector-Plus (K252190) | Aitewan Biomedical Technology, Inc. | 2026-04-10 |
| Freestyle Mini Hands-free (K253510) | Medela, LLC | 2026-04-10 |
| CoAptix S System (K252699) | University of Utah, Department of Orthopaedics | 2026-04-10 |
| VRNT (K254004) | Cognifisense, Inc. | 2026-04-10 |
| ARION ARC System (K253917) | Plasma Surgical, Inc. | 2026-04-10 |
| Auryon Atherectomy System (K260244) | Eximo Medical | 2026-04-10 |
| LOBO Vascular Occlusion System (K260508) | Okami Medical, Inc. | 2026-04-10 |
| syngo Dynamics (VA41F) (K253689) | Siemens Healthcare GmbH | 2026-04-10 |
| EASYMADE-TI (K252251) | CG Bio Co., Ltd. | 2026-04-09 |
| Seaman Pro/Seaman (K252228) | Checkcells, Inc. | 2026-04-09 |
| Eternal Art Porcelain Powders (K260067) | Shandong Huge Dental Material Corporation | 2026-04-09 |
| LOCATOR® Angled Abutment (K260555) | Zest Anchors, LLC | 2026-04-09 |
| Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (K252929) | Anhui Happiness Workshop Instruments Co., Ltd. | 2026-04-09 |
| Artelon Convenience Kits (K260317) | International Life Sciences | 2026-04-09 |
| SILKBridge (K260245) | KLISBio S.r.l. | 2026-04-09 |
| Accuro XV (K254021) | Rivanna Medical, Inc. | 2026-04-09 |
| Radical 6F Access Catheter (K253975) | Maduro Medical, Inc. | 2026-04-09 |
| SPINEART Navigation Instrument System (K254158) | Spineart SA | 2026-04-09 |
| RCT800 (K260462) | Ray Co., Ltd. | 2026-04-09 |
| Picosecond Nd:YAG Laser Systems (Model: HS-298) (K260017) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 |
| Wearable Breast Pump (Model S21A) (K260033) | Shenzhen TPH Technology Co., Ltd. | 2026-04-08 |
| LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (K260420) | MacroLux Medical Technology Co., Ltd. | 2026-04-08 |
| Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) (K254258) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-08 |
| Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (K253268) | CMT Health PTE., Ltd. | 2026-04-08 |
| Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (K260197) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
| myAir (K251889) | Resmed Corp | 2026-04-08 |
| OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) (K260816) | Boston Scientific | 2026-04-08 |
| Hemoclip (K252270) | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 |
| Apex Locator (FindPex) (K252224) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 |
| CATAMARAN™ SI Joint Fusion System (K260477) | Tenon Medical | 2026-04-08 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K251666) | STERIS Corporation | 2026-04-08 |
| TL-10 Laparoscopic Scope Cleaner (K260089) | Scopix , Ltd. | 2026-04-08 |
| Pivot Insulin Delivery System (K253534) | Modular Medical | 2026-04-08 |
| Celerity 5 HP Biological Indicator (LCB052) (K260766) | STERIS Corporation | 2026-04-08 |
| ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (K253801) | Anumana, Inc. | 2026-04-07 |
| IWD-Gel™ (K254191) | InnovaCorium, Inc. | 2026-04-07 |
| Voyager DSLT (430840610) (K252979) | Belkin Vision, Ltd. | 2026-04-07 |
| Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) (K260466) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 |
| Warming System (K252861) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 |
| AuST Steerable Sheath (K260942) | CenterPoint Systems, LLC | 2026-04-07 |
| Power Wheelchair (OS-R-M01S) (K253952) | Beijing OrionStar Technology Co., Ltd. | 2026-04-07 |
| Elecsys Anti-HBc IgM (K260049) | Roche Diagnostics | 2026-04-07 |
| Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) (K260860) | Basic Medical Technology, Inc. | 2026-04-07 |
| Firefighter™ Pro PTCA Balloon Catheter (K252116) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 |
| PrimeSight UltraView System (K253905) | Cogentix Medical, Inc. | 2026-04-07 |
| Elecsys Anti-HBc II (K260046) | Roche Diagnostics | 2026-04-07 |
| Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) (K253946) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-07 |
| Elecsys Anti-HAV IgM (K260048) | Roche Diagnostics | 2026-04-07 |