| Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (K253479) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 |
| Wearable Electric Breast Pump (YM-8803) (K252754) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 |
| JOULE 1064nm System and Accessories (K251077) | Sciton, Inc | 2025-12-19 |
| Endura™ Ureteral Stent and Stent Set (K251469) | Cathegenix (Xiamen) Co., Ltd. | 2025-12-19 |
| iCEM Universal Plus (K254063) | Kulzer, LLC | 2025-12-19 |
| Chiavaye Personal Moisturizer (K251011) | Unipack, LLC | 2025-12-19 |
| Spo2 Sensor CSS032D (K251751) | Shenzhen Ykd Technology Co., Ltd. | 2025-12-19 |
| Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (K253358) | Diazyme Laboratories, Inc. | 2025-12-19 |
| STAR Apollo™ Mapping System (K253733) | Rhythm AI, Ltd. | 2025-12-19 |
| CO2 Laser Therapy System (Model: LFS-D9U) (K250998) | Sanhe Lefis Electronics Co., Ltd. | 2025-12-19 |
| CE Deliver (DLV) (K252480) | CapsoVision, Inc. | 2025-12-19 |
| Tru Liver Health Test Panel (K251074) | Truvian Health | 2025-12-19 |
| ClearCalc Model RADCA V2.6 (K252863) | Radformation, Inc. | 2025-12-19 |
| eMurmur Heart AI (K252284) | Csd Labs | 2025-12-19 |
| Pectus Versa System (K251050) | Gm Dos Reis Industria E Comercio | 2025-12-19 |
| LIA Console (542-7) (K251730) | Leadoptik, Inc. | 2025-12-19 |
| IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (K253577) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 |
| ProtekDilate Vascular Access Kit (K253616) | Sorin Group Italia S.R.L. | 2025-12-19 |
| Vivo 45 LS (K232365) | Oconnell Regulatory Consultants, Inc. | 2025-12-19 |
| MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise (K252838) | Siemens Healthcare GmbH | 2025-12-19 |
| LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (K253054) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | 2025-12-19 |
| Balanced Knee System TriMax Porous Femoral Components (K253161) | Ortho Development Corp. | 2025-12-19 |
| EMPOWR Knee (K252974) | Encore Medical L.P. | 2025-12-19 |
| Southern Craniomaxillofacial (CMF) System (K253373) | Southern Medical (Pty) , Ltd. | 2025-12-19 |
| ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) (K252793) | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2025-12-18 |
| SIMDA Abutments (K252320) | Simda Co., Ltd. | 2025-12-18 |
| RefleXion Medical Radiotherapy System, Reflexion X2 (K252071) | Reflexion Medical, Inc. | 2025-12-18 |
| OTSCneo System Set (100.03n-14n, 100.27n-31n) (K251562) | Ovesco Endoscopy AG | 2025-12-18 |
| MediAI-BA (K250914) | Crescom Co., Ltd. | 2025-12-18 |
| Dental Cone; Dental Sponge (K253758) | Medizin Produkte Neustadt GmbH (Mpn) | 2025-12-18 |
| Tomey Optical Biometer OA-2000 (OA-2000) (K252348) | Tomey Corporation | 2025-12-18 |
| Single Use Cytology Brush V (BC-V600P-3010) (K250993) | Olympus Medical Systems Corporation | 2025-12-18 |
| Midline Catheter (K252402) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 |
| Amethyst HP PTA OTW 0.035 Catheter (K251915) | Natec Medical , Ltd. | 2025-12-18 |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (K252533) | Edwards Lifesciences | 2025-12-18 |
| Helo Thrombectomy System (K252956) | Endovascular Engineering, Inc. | 2025-12-18 |
| PVAD IQ Software (K252235) | Ultrasight , Ltd. | 2025-12-18 |
| FX CorAL 40; FX CorAL 50 (K253518) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-12-18 |
| Park Dental Nylon MAD (K252976) | Park Dental Research Corp. | 2025-12-18 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |
| MOVIVA® Hybrid Ablation Probe (K253915) | Erbe Elektromedizin GmbH | 2025-12-18 |
| Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (K252417) | ABBOTT MEDICAL | 2025-12-17 |
| UltraSight Guidance (K251416) | Ultrasight , Ltd. | 2025-12-17 |
| Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) (K252983) | Shenzhen Goodwind Technology Development Co., Ltd. | 2025-12-17 |
| Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) (K250854) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-17 |
| ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) (K252739) | Ethicon Endo-Surgery, LLC | 2025-12-17 |
| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
| Elecsys Anti-SARS-CoV-2 (K253839) | Roche Diagnostics | 2025-12-17 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253710) | Dexcom, Inc. | 2025-12-17 |
| BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (K252191) | Bonebridge AG | 2025-12-17 |
| Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (K253719) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-12-17 |
| Intri26 Introducer Sheath (K252508) | Inari Medical, Inc. | 2025-12-17 |
| Neosoma Brain Mets (K252922) | Neosoma, Inc. | 2025-12-17 |
| SURFLO Hybria Closed System Safety IV Catheter (K252398) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-17 |
| DuoprossTM Smart Cap (Type I) (K252518) | Duopross Meditech Corporate | 2025-12-17 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K253721) | S.M.A.I.O | 2025-12-17 |
| ADVIA Centaur Cytokeratin Fragment 21-1 (K250925) | Fujirebio Diagnostics,Inc. | 2025-12-16 |
| Versius Surgical System (Versius Plus) (K252111) | Cmr Surgical Limited | 2025-12-16 |
| Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) (K252468) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2025-12-16 |
| Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (K251745) | Baxter Healthcare Corporation | 2025-12-16 |
| Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (K251951) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-12-16 |
| prolaio eVO2peak Module (Version 1.0) (K252204) | Prolaio, Inc. | 2025-12-16 |
| SKAN C PULSAR (K251893) | Skanray Technologies Limited | 2025-12-16 |
| BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology (K252373) | Spectrum Vascular | 2025-12-16 |
| VR® Personal Protective Level 3 Gown (VR Gowns) (K252940) | PolyConversions, Inc. | 2025-12-16 |
| PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) (K251256) | Pentax of America, Inc. | 2025-12-16 |
| IRISeg (K251763) | Intuitive Surgical, Inc. | 2025-12-16 |
| IDENTIFY (5.0) (K252919) | Varian Medical Systems, Inc. | 2025-12-16 |
| V series portable oxygen concentrator (V5, V5C, V6, V6C) (K252268) | Shenzhen Harveymed Technology Co., Ltd. | 2025-12-16 |
| Cambridge Partial Knee (K251771) | Signature Orthopaedics Pty, Ltd. | 2025-12-16 |
| TroClose 1200 (K253620) | Gordian Surgical, Ltd. | 2025-12-16 |
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |
| SleepRes PAP System (K251770) | Sleepres, Inc. | 2025-12-15 |
| Paradigm System (K252950) | Proprio, Inc. | 2025-12-15 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K251302) | Spineology, Inc. | 2025-12-15 |
| da Vinci SP Surgical System (SP1098) (K252675) | Intuitive Surgical, Inc. | 2025-12-15 |
| HyperVue™ Imaging System - Integrated (K253101) | Spectrawave, Inc. | 2025-12-15 |
| MFUSE (MS001) (K250319) | Machina Medical, Inc. | 2025-12-15 |
| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
| Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (K252898) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-12-15 |
| Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) (K252935) | Foshan Pingchuang Medical Technology Co., Ltd. | 2025-12-15 |
| FemVue® Controlled Saline-Air Device (FSA-300) (K253403) | Femasys, Inc. | 2025-12-15 |
| V•Stick™ Vascular Access Set (K253741) | Argon Medical Devices, Inc. | 2025-12-15 |
| Erchonia CLX (Model # CFL) (K252574) | Erchonia Corporation | 2025-12-15 |
| Hypnos (369054-200) (K250851) | Cadwell Industries, Inc. | 2025-12-14 |
| iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (K251085) | Ihealth Labs, Inc. | 2025-12-12 |
| EnCor EnCompass™ Breast Biopsy and Tissue Removal System (K252681) | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| Therapy US (K252273) | Dmc Importação E Exportação DE Equipamentos Ltda | 2025-12-12 |
| TRAUMAGEL® 2.0 Hemostatic Gel (K253609) | Cresilon, Inc. | 2025-12-12 |
| iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (K251092) | Ihealth Labs, Inc. | 2025-12-12 |
| Cerynë Intimate Care (K250488) | Ansella Therapeutics | 2025-12-12 |
| Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) (K250821) | Eurosets S.R.L | 2025-12-12 |
| TopCEM Vigor SA Self-Adhesive Resin Cement (K252785) | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 |
| Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) (K252745) | Micro-Energy Medical Technology Co., Ltd. | 2025-12-12 |
| Swoop® Portable MR Imaging® System (K253489) | Hyperfine, Inc. | 2025-12-12 |
| VaporShield (K250847) | Vault Paragon Group, Inc. | 2025-12-12 |
| EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (K251089) | Exelint International, Co. | 2025-12-12 |
| Self-Seal Sterilization Pouch and Roll (K251177) | Guangdong Maidi Medical Co., Ltd. | 2025-12-12 |
| FUJIFILM Ultrasonic Endoscope EB-710US (K250863) | Fujifilm Corporation | 2025-12-12 |
| Pterygoid Indication for GM Helix Implants (K252090) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 |