| LimFlow ARC (K251376) | LimFlow, Inc. | 2025-05-31 |
| Swoop® Portable MR Imaging® System (V2) (K250236) | Hyperfine, Inc. | 2025-05-30 |
| Wearable Breast Pump (Model S21) (K250368) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 |
| Motif Aura Glow breast pump (Model Motif Aura Glow) (K250365) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 |
| VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) (K250150) | Sorin Group Italia S.R.L. | 2025-05-30 |
| DentalJect (K243654) | Vapocoolshot, Inc. | 2025-05-30 |
| Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (K251238) | Maquet Cardiovascular, LLC | 2025-05-30 |
| 5008X Hemodialysis System (K243505) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-05-30 |
| Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (K250078) | Mindset Medical, Inc. | 2025-05-30 |
| TE Air Diagnostic Ultrasound System (K250024) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-30 |
| AudaxCeph Cephalogram Analysis Software (K243005) | Audax D.O.O. | 2025-05-30 |
| MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) (K250195) | Matelaser, Inc. | 2025-05-30 |
| Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce (K243010) | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 |
| Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) (K250957) | Olympus Medical Systems Corporation | 2025-05-30 |
| TekBrace Solo Soft Tissue Reinforcement Device (K251063) | Theramicro | 2025-05-30 |
| XBody Go USA, XBody Pro USA (K242926) | Xbody Hungary Kft. | 2025-05-30 |
| Endoscopic Distal Attachment (AF-D series) (K242635) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-05-30 |
| Allix5 (DEN240047) | Clairity, Inc. | 2025-05-30 |
| Dynamic TiBase (K243530) | Talladium España, SL | 2025-05-30 |
| BriefCase-Triage (K251406) | Aidoc Medical , Ltd. | 2025-05-30 |
| Prestige Coil System (Prestige Packing Line Extension) (K251383) | Balt USA, LLC | 2025-05-30 |
| EsFlow PLUS (K250317) | Spident Co., Ltd. | 2025-05-30 |
| VCFix Spinal System (K250637) | Amber Implants | 2025-05-30 |
| KALA Red Light Face Mask (KALA-01) (K250581) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-30 |
| LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (K242830) | Bonraybio Co., Ltd. | 2025-05-30 |
| ViVi® Toga Premium (K243522) | Thi Total Healthcare Innovation GmbH | 2025-05-30 |
| FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin (K242640) | Fertipro NV | 2025-05-30 |
| Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) (K242725) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-05-30 |
| Opulus™ Lymphoma Precision (K243863) | Roche Molecular Systems, Inc. | 2025-05-30 |
| OHC COVID-19 Antigen Self Test (K241313) | Osang, LLC | 2025-05-30 |
| ARIX Pectus Bar System (K242751) | Jeil Medical Corporation | 2025-05-30 |
| Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (K251315) | Remex Medical Corp. | 2025-05-29 |
| Visualase V2 MRI-guided Laser Ablation System (9736422) (K250307) | Medtronic Navigation | 2025-05-29 |
| Dental Barrier and Sleeves (K250606) | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025-05-29 |
| ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (K251340) | Epic Medical Pte. , Ltd. | 2025-05-29 |
| PM2+ System and SmartPICC Stylet (K243484) | Piccolo Medical, Inc. | 2025-05-29 |
| CERABIEN MiLai (K250673) | Kuraray Noritake Dental, Inc. | 2025-05-29 |
| Radius VSM and Accessories (K250757) | Masimo Corporation | 2025-05-29 |
| Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (K250215) | Cochlear | 2025-05-29 |
| BiliWrap (K243372) | Gerium Medical, Ltd. | 2025-05-29 |
| SuturePatch Tissue Reinforcement (K243480) | Arthrex, Inc. | 2025-05-29 |
| Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US (K243497) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-05-29 |
| Voluson™ Performance 16; Voluson™ Performance 18 (K250543) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-29 |
| 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (K243309) | Terumo Europe N.V. | 2025-05-29 |
| NEUROMARK System (NMK00301) (K250048) | Neurent Medical , Ltd. | 2025-05-29 |
| Spur Peripheral Retrievable Stent System (DEN240048) | Reflow Medical, Inc. | 2025-05-29 |
| VersaCross Connect™ Transseptal Dilator (K251325) | Baylis Medical Company, Inc. | 2025-05-29 |
| TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) (K243856) | Shenzhen Astec Technology Co., Ltd. | 2025-05-29 |
| SIGNEX (K243469) | Osteonic Co., Ltd. | 2025-05-29 |
| myAir (K250624) | Resmed Corp | 2025-05-28 |
| OsteoFlo HydroFiber (K243949) | SurGenTec, LLC | 2025-05-28 |
| MRidium 3870 MRI Infusion Pump System (3870) (K242752) | Iradimed Corporation | 2025-05-28 |
| Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. (K242793) | Shenzhen Insighters Medical Technology Co., Ltd. | 2025-05-28 |
| TAIMedImg DeepMets (K250427) | Taiwan Medical Imaging Co., Ltd. | 2025-05-28 |
| OptiMap™ System (K251344) | Boston Scientific Corporation | 2025-05-28 |
| Disposable Prophy Angle (K240950) | Pacific Care Limited | 2025-05-28 |
| Rapid MLS (K243378) | Ischemaview, Inc. | 2025-05-28 |
| Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (K242699) | Opcom Medical, Inc. | 2025-05-28 |
| Zionic Pro Max (Radiofrequency) (K243716) | Termosalud S.L. | 2025-05-28 |
| Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (K243047) | Imperative Care, Inc. | 2025-05-28 |
| Europa (Alternative: AiRTouch) portable X-ray system (K244049) | Livermoretech, Inc. | 2025-05-28 |
| CoLumboX (K250367) | Smart Soft Healthcare AD | 2025-05-28 |
| Neodent Implant System - Custom Abutments (K250614) | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2025-05-27 |
| Helios+ UV-C System (K242604) | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 2025-05-27 |
| Integral Dental Units (K242611) | Mipont Medical Equipment Co., Ltd. | 2025-05-27 |
| Dexter L6 System (K250435) | Distalmotion SA | 2025-05-27 |
| Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (K242841) | ABBOTT MEDICAL | 2025-05-27 |
| Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (K243777) | Theodent, LLC | 2025-05-27 |
| Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (K250475) | Ningbo Baichen Medical Devices Co., Ltd. | 2025-05-27 |
| DeepRhythmAI (K250932) | Medicalgorithmics S.A. | 2025-05-27 |
| BEAUTIFIL II (K251578) | Shofu Dental Corporation | 2025-05-27 |
| Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (K250573) | Olympus Medical Systems Corp. | 2025-05-27 |
| OSSIOfiber® Suture Anchor (K251309) | OSSIO , Ltd. | 2025-05-27 |
| Puritan PurSafe Plus Collection and Transport System (K242820) | Puritan Medical Products, LLC | 2025-05-27 |
| IPL400 (K250384) | El Global Trade, Ltd. | 2025-05-23 |
| Accuro 3S (K243937) | Rivanna Medical, Inc. | 2025-05-23 |
| Sil-Flow (K250778) | Dsi Dental Solutions, Ltd. | 2025-05-23 |
| ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (K251211) | ABBOTT MEDICAL | 2025-05-23 |
| Clever One (K250005) | Ewoosoft Co., Ltd. | 2025-05-23 |
| DEEPECHO (K242594) | Deepecho | 2025-05-23 |
| MagnetOs MIS (K243474) | Kuros Biosciences B.V | 2025-05-23 |
| RECLAIM Monobloc Revision Femoral Stem (K251292) | Depuy Ireland UC | 2025-05-23 |
| Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (K250938) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-05-23 |
| Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (K244047) | Venocare, Inc. | 2025-05-23 |
| Second Opinion® 3D (K243989) | Pearl, Inc. | 2025-05-23 |
| NeuroMatch (K250239) | LVIS Corporation | 2025-05-23 |
| WiZARD 520 Full Face Mask (K243023) | Wellell, Inc. | 2025-05-23 |
| FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (K243261) | Fujifilm Corporation | 2025-05-23 |
| 93 NeuFlex Catheter (K251044) | Piraeus Medical | 2025-05-23 |
| Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549) | The Binding Site Group , Ltd. | 2025-05-23 |
| Frida™ Anterior Cervical Plate System (K250446) | Spineup, Inc. | 2025-05-23 |
| Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| Knotilus+ Biocomposite Knotless Anchor (K250544) | Stryker Endoscopy | 2025-05-23 |
| RadiForce MX317W-PA (K242545) | Eizo Corporation | 2025-05-23 |
| SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (K250361) | Geske Beauty Tech GmbH | 2025-05-23 |
| Koala Intrauterine Pressure Catheter (IPC-5000E) (K250897) | Clinical Innovations, LLC | 2025-05-22 |
| YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (K250878) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 |
| Solawave 2-in-1 Skincare Mini (Model: 61043) (K250532) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-22 |
| Skin Clinic Freeze Point for Warts and Skin Tags (K251493) | Cryoconcepts LP | 2025-05-22 |
| Harioculture TL-16 Time-lapse Incubator (K242684) | Hua Yue Medical Technology Co., Ltd. | 2025-05-22 |