| Contour ProtégéAI+ (K253270) | Mim Software, Inc. | 2026-03-27 |
| EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (K254099) | Samsung Medison Co., Ltd. | 2026-03-27 |
| Butterfly Gestational Age Tool (K252148) | Butterfly Network, Inc. | 2026-03-27 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (K253625) | Canon Medical Systems Corporation | 2026-03-27 |
| ARTICOR planner (K252195) | Artiness S.R.L | 2026-03-27 |
| SF Push-in Anchor (K260294) | Surgical Fusion Technologies GmbH | 2026-03-27 |
| SportLinc Syndesmosis Device (K252081) | Lincotek Medical | 2026-03-27 |
| Stealth AXiS Cranial clinical application (K253379) | Medtronic Navigation, Inc. | 2026-03-26 |
| SwiftMR (K253775) | Airs Medical, Inc. | 2026-03-26 |
| Lunit INSIGHT DBT (V1.2) (K253796) | Lunit, Inc. | 2026-03-26 |
| Multiflex Steerable Sheath 17.5F (K260626) | Vizaramed, Inc. | 2026-03-26 |
| Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (K252926) | Restore Robotics | 2026-03-26 |
| DeVilbiss 5 Liter Oxygen Concentrator (555) (K253549) | Devilbiss Healthcare, LLC | 2026-03-26 |
| REAL INTELLIGENCE™ CORI™ (K260601) | Blue Belt Technologies, Inc. | 2026-03-26 |
| Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (K260273) | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 |
| VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281) | BIOMERIEUX | 2026-03-26 |
| Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) (K253627) | Surgify Medical OY | 2026-03-26 |
| Flex-Z™ Cervical Cage (K252432) | Spinepoint, LLC | 2026-03-25 |
| MiraChlor Antimicrobial Wound Solution (K252023) | Letus Corporation | 2026-03-25 |
| Airlock® Ankle Plating System (K260274) | Novastep SAS | 2026-03-25 |
| Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (K252908) | Sandstone Medical (Suzhou), Inc. | 2026-03-25 |
| Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) (K253184) | Zhuhai Wesee Meditech Co., Ltd. | 2026-03-25 |
| Vortex5 Tailor's Bunion Correction System (K260291) | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) (K253322) | Medline Industries, LP | 2026-03-25 |
| Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (K252052) | Bausch and Lomb, Incorporated | 2026-03-25 |
| Arterial Pressure Monitoring Set/Tray (K254278) | Spectrum Vascular | 2026-03-25 |
| LYNX COBLATION Laryngeal Wand (72290254) (K253680) | ArthroCare Corporation | 2026-03-25 |
| CUVIS-joint (CJ150) (K252037) | Curexo, Inc. | 2026-03-25 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K253406) | Mevion Medical Systems, Inc. | 2026-03-25 |
| Invictus Bands System (K253615) | Alphatec Spine, Inc. | 2026-03-25 |
| Trinias (K252099) | Shimadzu Corporation | 2026-03-24 |
| NanoKnife Generator (H78720300351US0) (K253198) | Angiodynamics | 2026-03-24 |
| LOQTEQ® VA Proximal Humerus Plate 3.5 (K254253) | Aap Implantate AG | 2026-03-24 |
| PRESSONE™ (K253047) | Nipro Medical Corporation | 2026-03-24 |
| Electric Wheelchair (E201) (K254012) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | 2026-03-24 |
| LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power (K260673) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-03-24 |
| FebriDx Bacterial/Non-bacterial Assay (K260787) | Lumos Diagnostics, Inc. | 2026-03-24 |
| JLK-NCCT (K252421) | JLK, Inc. | 2026-03-24 |
| Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (K260087) | GE Medical Systems SCS | 2026-03-24 |
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
| MDx-Chex for BCN (K254166) | Streck | 2026-03-23 |
| QuikFix External Fixator: Knee-Spanning Pack (K260112) | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| Adin Long Dental Implant System (K252031) | Adin Dental Implant Systems , Ltd. | 2026-03-23 |
| True Definition DL (K253686) | Ge Healthcare Japan Corporation | 2026-03-23 |
| Clavicle Fixation System (K254288) | Skeletal Dynamics, Inc. | 2026-03-23 |
| HyperSuture All Green Extension Line (K254275) | Threadstone, LLC | 2026-03-23 |
| LED Light Therapy Masks (LumiLips FAC07NA) (K260202) | Guangdong Newdermo Biotech Co., Ltd. | 2026-03-23 |
| CT Rembra RT; CT Areta RT; CT Rembra (K252992) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| NOMAD Pro 3 (K253864) | Dental Imaging Technologies Corporation | 2026-03-20 |
| Livi Device (K252005) | Liviwell, Inc. | 2026-03-20 |
| FLOWRUNNER Aspiration System (K254208) | Expanse Medical, Inc. | 2026-03-20 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K253098) | Nexstim Oyj | 2026-03-20 |
| Bifix Veneer LC, Bifix Veneer Try-In (K252606) | Voco GmbH | 2026-03-20 |
| TiLink-L Navigation Instruments (K253604) | SurGenTec, LLC | 2026-03-20 |
| Valvuloplasty Balloon Catheter (ValvuloPro) (K260437) | Dongguan TT Medical, Inc. | 2026-03-20 |
| Arthrex Humeral Nails (K252016) | Arthrex, Inc. | 2026-03-20 |
| Arthrex FiberTak Suture Anchor (K260561) | Arthrex, Inc. | 2026-03-20 |
| HemosIL Factor V Leiden (APC Resistance V) (K260551) | Instrumentation Laboratory (IL) Co. | 2026-03-20 |
| Smart Fit TorsoCardiac 1.5T (K260519) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-20 |
| nordicAudio (1.0) (K251937) | Nordicneurolab AS | 2026-03-20 |
| Photonova Spectra, Photonova Spectra Select (K253520) | Ge Medical Systems, LLC | 2026-03-20 |
| FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 (K260544) | FMD Co., Ltd. | 2026-03-20 |
| Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) (K251950) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-03-20 |
| Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (K252050) | Olympus Medical Systems Corporation | 2026-03-20 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K252358) | Nexstim Oyj | 2026-03-20 |
| ClaveQS™ Bag (K251980) | Icu Medical, Inc. | 2026-03-20 |
| Electric wheelchair (JJW-7002, JJW-7003) (K253849) | ZheJiang J&J Mobility Co., Ltd. | 2026-03-20 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| Percutaneous Endoscopic Gastrostomy (PEG) Kit (K254170) | Degania Silicone , Ltd. | 2026-03-20 |
| Noxturnal Web (K260585) | Nox Medical Ehf | 2026-03-20 |
| Derma-Gide (K260532) | Geistlich Pharma AG | 2026-03-19 |
| JWG-1 (K252101) | Yamaha Motor Co., Ltd. | 2026-03-19 |
| DiversiVy™ Facet Screw System (K253432) | Vy Spine, LLC | 2026-03-19 |
| Willow 24 Guidewire (K260537) | Arbor Endovascular, LLC | 2026-03-19 |
| CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (K253965) | Wuhan PHOMED Technology Company , Ltd. | 2026-03-19 |
| CastleLoc Pectus Bar System (K260448) | L&K BIOMED Co., Ltd. | 2026-03-19 |
| Dia-X Sil Bite (K254112) | DiaDent Group International | 2026-03-19 |
| AutoContour (RADAC V5) (K260509) | Radformation, Inc. | 2026-03-19 |
| Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K254269) | St. shine Optical Co., Ltd. | 2026-03-19 |
| Disposable Distal Cap (K253139) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-03-19 |
| Enroute 0.014'' Transcarotid Guidewire (K253746) | Lake Region Medical | 2026-03-19 |
| ELISIO™-H (K260533) | Nipro Medical Corporation | 2026-03-19 |
| EUROPA™ Posterior Cervical Fusion Navigated Instruments (K253444) | MiRus, LLC | 2026-03-18 |
| LimFlow Vector (K260188) | LimFlow, Inc. | 2026-03-18 |
| syngo.via RT Image Suite VC10 (K252304) | Varian Medical Systems, Inc. | 2026-03-18 |
| APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (K260830) | Sangi Co., Ltd. | 2026-03-18 |
| VISUREF 600 (K253834) | Carl Zeiss Vision GmbH | 2026-03-18 |
| DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (K254110) | MedShape, Inc. | 2026-03-18 |
| Safety Pen Needle (K253622) | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor (K251967) | O&M Halyard, Inc. | 2026-03-18 |
| AlignRT Plus (8.0) (K253012) | Vision Rt, Ltd. | 2026-03-18 |
| Fusion FibFix Nail (K252961) | Fusion Orthopedics USA, LLC | 2026-03-18 |
| enCore Impression Material (K251926) | Encore Guards | 2026-03-17 |
| APS Spear Locking Plate (K254053) | A Plus Biotechnology Co., Ltd. | 2026-03-17 |
| Electrical Scooter (SM4226) (K252813) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | 2026-03-17 |
| Tyto Insights for Eardrum Bulging Detection (DEN250014) | Tyto Care , Ltd. | 2026-03-17 |
| BTL-785NEH (K253750) | BTL Industries, Inc. | 2026-03-17 |
| GUARDIAN™ Quick Dip Residual Chlorine (5212) (K253863) | Serim Research | 2026-03-17 |
| Grappler Suture Anchor PCFD Tether System (K253886) | Paragon 28, Inc. | 2026-03-17 |
| EchoNavigator R5.0 (K253614) | Philips Medical Systems Nederland B.V. | 2026-03-17 |