| SPECTRA Wearable 2 (K250208) | Uzinmedicare Co., Ltd. | 2026-04-06 |
| APERTO Lucent MRI System (K253862) | Fujifilm Corporation | 2026-04-06 |
| ProSomnus RPMO2 OSA Device (RPMO2 OSA) (K252765) | Prosomnus Sleep Technologies | 2026-04-06 |
| SV70 Ventilator (SV70) (K252182) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 |
| SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (K260397) | Hironic Co., Ltd. | 2026-04-06 |
| ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (K260521) | Zhuhai Pusen Medical Technology Co., Ltd. | 2026-04-06 |
| GLOSSY COAT (15ML) (K254091) | YAMAHACHI DENTAL MFG., Co. | 2026-04-06 |
| VANES Delivery System (VDS) (K260459) | Zoll Respicardia, Inc. | 2026-04-06 |
| Ricoh 3D for Healthcare Bolus (K253025) | Ricoh 3D For Healthcare, LLC | 2026-04-06 |
| in2 Smart (in2S) (K252809) | Virility Medical , Ltd. | 2026-04-06 |
| AETOS Shoulder System - CONCELOC Glenoids (K254084) | Smith & Nephew, Inc. | 2026-04-06 |
| 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K253288) | Esaote, S.p.A. | 2026-04-06 |
| Light-curing Coloring Materials (ALCM) (K253036) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| Tyber Medical Trauma Screw (K253042) | Tyber Medical, LLC | 2026-04-03 |
| mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) (K260718) | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 |
| mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 (K260719) | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 |
| MAGENTIQ-COLO (ME-APDS) (K260724) | Magentiq Eye, Ltd. | 2026-04-03 |
| Single-use Video Scope; PB Digital Controller (K254153) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-03 |
| neuropacs (DEN240071) | Automated Imaging Diagnostics, LLC | 2026-04-03 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K260786) | S.M.A.I.O | 2026-04-03 |
| Hot and Cold Compression System (A02-C-032) (K252386) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-03 |
| Ceribell Brain Monitor Headband (K260363) | Ceribell, Inc. | 2026-04-03 |
| Life Saving Tourniquet (K254060) | TW Medical | 2026-04-03 |
| uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K260524) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 |
| ClearCheck (RADCC V2.7) (K253962) | Radformation, Inc. | 2026-04-03 |
| HYALEX® MTP Hemiarthroplasty Implant (K250074) | Hyalex Orthopaedics, Inc. | 2026-04-03 |
| Electric Wheelchair (AL-208S-063) (K253340) | Zhongshan A&J Medical Equipment Co., Ltd. | 2026-04-03 |
| LSSA (NP-200) (K252495) | Newpong Co., Ltd. | 2026-04-03 |
| Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (K252744) | Cixi Ruihong Electric Appliance Co., Ltd. | 2026-04-03 |
| Disposable Stone Extraction Basket (K253056) | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-04-03 |
| Blueprint Patient-Specific Instrumentation (K253674) | Stryker Corporation (Tornier, S.A.S.) | 2026-04-03 |
| mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (K260720) | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 |
| Etiometry Platform (K254066) | Etiometry, Inc. | 2026-04-03 |
| Onclarity™ Self-Collection Kit (K260184) | Becton, Dickinson and Company | 2026-04-02 |
| LifeShield Infusion Safety Software Suite (K252130) | Icu Medical, Inc. | 2026-04-02 |
| Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (K252198) | Medical Brands Laboratories B.V. | 2026-04-02 |
| SMART M-CELL Bone Marrow Concentration System (K250518) | Miracell Co., Ltd. | 2026-04-02 |
| FLASH Flex™ Aorto-Ostial Angioplasty System (K254022) | Verge Medical, Inc. | 2026-04-02 |
| Tina-quant Cardiac high sensitivity CRP III (K260026) | Roche Diagnostics | 2026-04-02 |
| Leforte MMF System (K252246) | Jeil Medical Corporation | 2026-04-02 |
| Cryopush Cold Compression Device (A02-P-001) (K253076) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-02 |
| Tahoe Unicondylar Knee System with TiNbN Overcoat (K260796) | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
| Wireless Probe Type Ultrasound Scanner (K252709) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2026-04-02 |
| BELLIGER ACE (K252229) | Genoray Co., Ltd. | 2026-04-02 |
| SMART M-CELL PRP Concentration System (K250516) | Miracell Co., Ltd. | 2026-04-02 |
| BD Insyte™ IV Catheter (K252137) | Becton Dickinson Infusion Therapy Systems, Inc. | 2026-04-02 |
| Disposable Infusion Bag for Parenteral Nutrition (K252079) | Beijing L&Z Medical Technology Development Co., Ltd. | 2026-04-02 |
| SPECCHIO (K260647) | El.En S.P.A. | 2026-04-02 |
| GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (K252943) | Convatec Limited | 2026-04-01 |
| CoLumbo C-Spine (K254015) | Smart Soft Healthcare AD | 2026-04-01 |
| Medical Imaging Calibration Feature (MICF) (K253582) | Apple, Inc. | 2026-04-01 |
| enHAnce PEEK Bunion System (K253718) | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
| Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (K260007) | Hudi Pharma Srl | 2026-04-01 |
| GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only (K252876) | Shenzhen RF Tech Co., Ltd. | 2026-04-01 |
| Synchrony (K253473) | Stereotaxis, Inc. | 2026-04-01 |
| MOD-C (K242303) | Orthomod, LLC | 2026-04-01 |
| Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (K252513) | Poly Medicure Limited | 2026-04-01 |
| Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro (K260276) | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 |
| Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) (K254225) | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 |
| RM Electrode (RMH 25-01) (K253586) | Retmap, Inc. | 2026-04-01 |
| Prana System (K253405) | Prana Surgical | 2026-04-01 |
| InjecSURE Injection System (K253598) | Carbon Medical Technologies, Inc. | 2026-03-31 |
| Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (K260093) | VATECH Co., Ltd. | 2026-03-31 |
| Nd: YAG Laser Therapy Systems (K260375) | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| RW-1 (K253029) | Mediott, Inc. | 2026-03-31 |
| Safety lancet (XXXVII) (K260191) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 |
| K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR)) (K260319) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 |
| AiORTA - Plan v2.0 (K254207) | ViTAA Medical Solutions, Inc. | 2026-03-30 |
| Francisella tularensis Real-time PCR Assay (K260812) | Centers for Disease Control and Prevention | 2026-03-30 |
| FINDER Flu A&B/SARS-CoV-2 Test (K252269) | Baebies, Inc. | 2026-03-30 |
| IntelliVue Measurement Rack 6000 (867317) (K253654) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 |
| implantcast Packaging System Update (K260037) | Implantcast GmbH | 2026-03-30 |
| FLOW FLEXTEND Wand (72290039) (K254122) | ArthroCare Corporation | 2026-03-30 |
| Sagami Original 002 Polyurethane Male Condom (K252158) | Mayer Laboratories | 2026-03-30 |
| Avatar Medical Vision (K253950) | Avatar Medical | 2026-03-30 |
| Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (K252240) | Spectrum Spine | 2026-03-30 |
| Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K260370) | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026-03-30 |
| CO2 Laser System (K260257) | Sanhe Meditech Co., Ltd. | 2026-03-28 |
| ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (K252360) | Anumana, Inc. | 2026-03-28 |
| Spectral CT Verida Family (K253649) | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| Electric wheelchair (K253307) | Foshan Dahao Medical Technology Co., Ltd. | 2026-03-27 |
| AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (K260255) | Aventix Medical, Inc. | 2026-03-27 |
| ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (K252893) | Aneuvo | 2026-03-27 |
| SYMPHONY Navigation Ready Instruments (K260240) | Medos International SARL | 2026-03-27 |
| Strauss Surgical cystoscope, hysteroscope and accessories Instruments (K260271) | American Medical Endoscopy, Inc. | 2026-03-27 |
| STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device (K253572) | ETHICON, Inc. | 2026-03-27 |
| Automated Aortic Stenosis Software (AutoAS) (K254161) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 |
| Synergy Disc Instruments (K253392) | Synergy Spine Solutions, Inc. | 2026-03-27 |
| S-scan Open (100001800) (K260746) | Esaote, S.p.A. | 2026-03-27 |
| MedCAD® AccuStride™ System (K252064) | Medcad | 2026-03-27 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |
| Ryurei (K252295) | Terumo Corporation | 2026-03-27 |
| CyClean Cord (K254239) | SS GLOBAL | 2026-03-27 |
| Power wheelchair (ZS-EW8026) (K254206) | Ningbo Zhishan Medical Technology Co., Ltd. | 2026-03-27 |
| Electrically Powered Wheelchair (Model YC-01) (K253980) | Yurob Rehabilitation Medical Co., Ltd. | 2026-03-27 |
| EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K253595) | Philips Ultrasound, LLC | 2026-03-27 |
| MDx-Chex for BCP (K260041) | Streck, LLC | 2026-03-27 |
| GPA (hexafocon A) Rigid Gas Permeable Contact Lenses (K253822) | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026-03-27 |
| OTTO™ Disinfecting Cap (K252006) | Icu Medical, Inc. | 2026-03-27 |
| VyPlate™ Anterior Cervical Plate System (K260697) | Vy Spine, LLC | 2026-03-27 |