| Sonicaid Team3 (K250777) | Huntleigh Healthcare , Ltd. | 2025-09-19 |
| Tapestry Biointegrative Implant (K252647) | Embody, Inc. | 2025-09-19 |
| UniBur (K252662) | Nakanishi, Inc. | 2025-09-19 |
| Single Use Suction-Evacuation Ureteral Access Sheath (K250128) | Anhui Happiness Workshop Medical Instruments Co., Ltd. | 2025-09-19 |
| IPGTFL-02 (K251100) | Ipg Medical Corporation | 2025-09-19 |
| Videa Dental AI (K251002) | Videahealth, Inc. | 2025-09-19 |
| Purema H Hemoconcentrator - Pediatric (K243920) | Medica USA, Inc. | 2025-09-19 |
| Well-Root PT (K252285) | Vericom Co., Ltd. | 2025-09-19 |
| Alegria Flash ENA Screen (K250408) | Zeus Scientific | 2025-09-19 |
| Impact PEEK Union Nail System (K252657) | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| Portable mesh nebulizer (JM821) (K244035) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 |
| VEGA (K242859) | Ibramed Equipamentos Médicos | 2025-09-19 |
| EQUIA LC ONE (K250953) | GC America, Inc. | 2025-09-19 |
| uDR Aurora CX (K251167) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 |
| VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) (K251689) | Nakanishi, Inc. | 2025-09-19 |
| Unscented menstrual three-piece applicator tampon (K252613) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-09-19 |
| xR IVD (K241868) | Tempus AI, Inc. | 2025-09-19 |
| BondEase 2 Topical Skin Adhesive (K243990) | Optmed, Inc. | 2025-09-19 |
| Electric Wheelchair (Model P2) (K252428) | Superpi Robot Co., Ltd. | 2025-09-18 |
| ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (K250883) | Olympus Medical Systems Corporation | 2025-09-18 |
| Normatec Elite Hip (K251905) | NormaTec Industries, LP | 2025-09-18 |
| Sunny Plus (Sunny) (K251649) | ShenB Co., Ltd. | 2025-09-18 |
| Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) (K251479) | Mobarn Medical Devices, LLC | 2025-09-18 |
| Axial3D Insight (K250369) | Axial Medical Printing Limited | 2025-09-18 |
| InnerView System (K251597) | Perimetrics, Inc. | 2025-09-18 |
| Magic InBra (K251377) | Medela AG | 2025-09-18 |
| PlasmaFlow X Compression Sleeve Device (XPF0001) (K251446) | Manamed, LLC | 2025-09-17 |
| FG Bone Graft M (K244006) | Full Golden Biotech Co., Ltd. | 2025-09-17 |
| Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (K251623) | Shenzhen Yicai Health Technology Co., Ltd. | 2025-09-17 |
| ECHELON Synergy (K251386) | Fujifilm Corporation | 2025-09-17 |
| Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K251095) | Pegavision Corporation | 2025-09-17 |
| Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (K251221) | Abbott | 2025-09-17 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| Double Tube Herbst Appliance (K243752) | The Tmj Clinic PC | 2025-09-17 |
| DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) (K252035) | Kamemizu Chemical Industry Co., Ltd. | 2025-09-17 |
| Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (K251902) | Vitacore Industries, Inc. | 2025-09-17 |
| Ruthless Spine RJB (K252615) | Ruthless, LLC Dba Ruthless Spine | 2025-09-17 |
| SFIT Abutment (K242287) | Cowellmedi Co., Ltd. | 2025-09-16 |
| ACCUJECT Injector Set 2.1-1P (LP604590) (K252540) | Medicel AG | 2025-09-16 |
| Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) (K251676) | Microtek Medical, LLC | 2025-09-16 |
| Insight Enhanced™ DRF (EN-1002-01) (K251650) | Imaging Engineering, LLC | 2025-09-16 |
| Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K252598) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-09-15 |
| SpaceFix Shoulder Spacer (K252443) | G21, S.R.L. | 2025-09-15 |
| iGPS Navigation Instruments (K251780) | SI-BONE, Inc. | 2025-09-15 |
| Zener® (model ZEN-001-B1) (K252128) | Uvx, Inc. | 2025-09-15 |
| Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (K251869) | Premium Plus (Dongguan) Limited | 2025-09-15 |
| InferOperate Suite (K250237) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025-09-15 |
| IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) (K251914) | Miley Technology (Hebei) Co., Ltd. | 2025-09-15 |
| Sober Self-Test (K250609) | Sober Ip, LLC | 2025-09-15 |
| CloudTMS Edge (K250689) | Teleemg, LLC | 2025-09-14 |
| BrainsWay Deep TMS System (K251449) | Brainsway , Ltd. | 2025-09-13 |
| Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (K252554) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 |
| BONX805 (K243864) | Bontech Co., Ltd. | 2025-09-12 |
| ViewMateTM Ultrasound System (K251820) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-12 |
| Legend X Platform (K252576) | Pollogen, Ltd. | 2025-09-12 |
| Compact II (K251083) | Enraf-Nonius, B.V. | 2025-09-12 |
| bite away two (K250047) | mibeTec GmbH | 2025-09-12 |
| Erchonia EVRL (K251843) | Erchonia Corporation | 2025-09-12 |
| Vertex(TM) Catheter (K252027) | Jupiter Endovascular | 2025-09-12 |
| uWS-Angio (K250040) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K250986) | Mevion Medical Systems, Inc. | 2025-09-12 |
| LED Light Therapy Mask (2311, 2344, 2457, 2458) (K252189) | Dongguan Yanxi Technology Co., Ltd. | 2025-09-12 |
| Volta AF-Xplorer II (K251518) | Volta Medical | 2025-09-12 |
| CADDIE (K252586) | Odin Medical Limited | 2025-09-12 |
| Fast Warm - NX (K250445) | Fujifilm Irvine Scientific | 2025-09-12 |
| LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) (K252593) | Boston Scientific Corporation | 2025-09-12 |
| FETOLY (K251368) | Diagnoly | 2025-09-12 |
| Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller (K251170) | Tangent Endoscopy, LLC | 2025-09-12 |
| DynaNail TTC Fusion System (K250628) | MedShape, Inc. | 2025-09-12 |
| PowerKnot High Strength Sutures (K252225) | Medacta International S.A. | 2025-09-12 |
| Spine & Trauma Navigation Instruments (K252562) | Brainlab AG | 2025-09-12 |
| BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (K250059) | Becton, Dickinson and Company | 2025-09-12 |
| Stethophone Pro (K252595) | Sparrow Acoustics, Inc. | 2025-09-12 |
| Vivatmo pro-S (K243926) | Bosch Healthcare Solutions GmbH | 2025-09-11 |
| RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (K251826) | Smith & Nephew Medical, Ltd. | 2025-09-11 |
| UV5000 Handle (K250797) | Uroviu Corporation | 2025-09-11 |
| Nylon flexTAP(R) (K252374) | Airway Technologies D/B/A Airway Management | 2025-09-11 |
| Mazor X System / Mazor X Stealth Edition (K251316) | Mazor Robotics , Ltd. | 2025-09-11 |
| OsteoProbe (OP-100) (K250216) | Active Life Scientific, Inc. | 2025-09-11 |
| Serafin® (K251758) | Tns Co., Ltd. | 2025-09-11 |
| SEFRIA™ Hydrocodone Oral Fluid (K252520) | Immunalysis Corporation | 2025-09-11 |
| SIGNA™ Sprint (K251399) | Ge Medical Systems, LLC | 2025-09-11 |
| Hypertension Notification Feature (HTNF) (K250507) | Apple, Inc. | 2025-09-11 |
| PowerWire® 14 Radiofrequency Guidewire Kit (K251158) | Baylis Medical Technologies, Inc. | 2025-09-11 |
| Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) (K242314) | Augment Intelligent Medical System (China) Co., Ltd. | 2025-09-11 |
| XTRA4 (K251320) | Al.Chi.Mi.A. S.R.L | 2025-09-11 |
| OptiLUV Device (K250734) | Pollogen, Ltd. | 2025-09-10 |
| F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (K252173) | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 |
| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| da Vinci SP Surgical System (SP1098) (K251817) | Intuitive Surgical, Inc. | 2025-09-10 |
| Surfacer Inside-Out Access Catheter System (K252527) | Merit Medical System, Inc. | 2025-09-10 |
| VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (K251573) | Vizionfocus, Inc. | 2025-09-10 |
| OptiVu™ Shoulder (K252530) | Mr Surgical Solutions, LLC | 2025-09-10 |
| AngioWaveNet (K244002) | Angiowave Imaging, Inc. | 2025-09-10 |
| Enlight 2100 (TPL-E2103-0) (K250464) | Timpel S.A. | 2025-09-10 |
| Segmentron Viewer (K251072) | DGNCT, LLC | 2025-09-09 |
| Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) (K252180) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 |
| Quadsense (Quadsense and Quadsense Pro) (K252524) | Eventum Orthopaedics, Ltd. | 2025-09-09 |
| Edema Guard Monitor (EGM) CardioSet-001 (K250922) | Cardioset Medical , Ltd. | 2025-09-09 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |