| EsCem RMGI (K250566) | Spident Co., Ltd. | 2025-06-20 |
| External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (K242974) | Sophysa | 2025-06-20 |
| CollOvine™ Wound Dressing (K242985) | Ovigenex, LLC | 2025-06-20 |
| MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (K251258) | Medtronic, Inc. | 2025-06-20 |
| TMINI Miniature Robotic System (K250877) | THINK Surgical, Inc. | 2025-06-20 |
| HybridAPC probe (K243120) | Erbe Elektromedizin GmbH | 2025-06-20 |
| Alinity i Rubella IgG (K243168) | Abbott Laboratories | 2025-06-20 |
| Disposable Endoscopy Valve Set (K250732) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025-06-20 |
| Medconn Glycated Hemoglobin Test system (K242911) | Shanghai Medconn Medical Technology Co., Ltd. | 2025-06-20 |
| PathPresenter Clinical Viewer (K250968) | Pathpresenter Corporation | 2025-06-20 |
| PAL Sterilization Case (K243589) | Microaire Surgical Instruments, LLC | 2025-06-20 |
| LED LIGHT MASK (A093) (K250880) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. | 2025-06-20 |
| Restrata Soft Tissue Reinforcement (STR) (K251224) | Acera Surgical, Inc. | 2025-06-20 |
| Navient Image Guided Navigation System (ENT) (955-NC-NC) (K243053) | Claronav | 2025-06-20 |
| CT Scanner TSX-501R/1 V11.1 (K243398) | Canon Medical Systems Corporation | 2025-06-20 |
| AdheResp Smart Breath-actuated Mesh Nebulizer (K250583) | Hcmed Innovations Co., Ltd. | 2025-06-20 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (K242843) | Thermo Fisher Scientific | 2025-06-20 |
| FloPatch FP120 (K251114) | Flosonics Medical | 2025-06-20 |
| Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944) | Leone S.P.A. | 2025-06-19 |
| EpiMonitor (K250515) | Empatica S.r.l. | 2025-06-19 |
| Electrosurgical Pads (K251235) | Baisheng Medical Co., Ltd. | 2025-06-19 |
| Procedure mask/Surgical mask/Face mask (K250082) | Winner Medical Co., Ltd. | 2025-06-18 |
| CardIQ Suite (K243672) | GE Medical Systems SCS | 2025-06-18 |
| SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) (K242894) | Shanghai Saints Sages Surgical Co., Ltd. | 2025-06-18 |
| Extracorporeal Shock Wave Lithotripter (U200) (K242922) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 |
| FlexiGo 3D Delivery Catheter (K250492) | CenterPoint Systems, LLC | 2025-06-18 |
| Virata Spinal Fixation System (K250908) | SeaSpine Orthopedics Corporation | 2025-06-18 |
| Ureteral Stents (AF-D series) (K243039) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-06-18 |
| Happy Health Home Sleep Test (K242224) | Happy Health, Inc. | 2025-06-18 |
| Bioline Dental Implant System (K250872) | Bioline Dental Implant Systems, Ltd. | 2025-06-18 |
| EyeQ nanoECP (K243014) | Eyeq, Inc. | 2025-06-18 |
| Enteral Drainage System, Enteral Medicine straw (K242917) | HMC Premedical S.p.A. | 2025-06-18 |
| SPINEART Navigation Instrument System (K242933) | Spineart SA | 2025-06-18 |
| 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (K243253) | Esaote, S.p.A. | 2025-06-18 |
| DRX9000C-SL Cervical Spinal Decompression System (K243366) | Excite Medical of Tampa Bay, LLC | 2025-06-18 |
| PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253) | Bard Access Systems, Inc. | 2025-06-18 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K250886) | Philips Ultrasound, LLC | 2025-06-18 |
| The Acumed Wrist Fixation System (K251296) | Acumed, LLC | 2025-06-18 |
| Mobility Scooter (JT10) (K243102) | Jiangxi Jiangte Electric Vehicle Co., Ltd. | 2025-06-18 |
| Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (K243172) | O&M Halyard, Inc. | 2025-06-18 |
| F&P Nova Nasal Mask (K243583) | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| CONMED Argo Knotless® Anchor (K251530) | Conmed Corporation | 2025-06-18 |
| Curiteva Porous PEEK Standalone ALIF System (K250845) | Curiteva, Inc. | 2025-06-18 |
| LZI Fentanyl III Enzyme Immunoassay (K251634) | Lin-Zhi International, Inc. | 2025-06-18 |
| Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (K243133) | Kl-Kepong Rubber Products Sdn. Bhd. | 2025-06-17 |
| SKR 3000 (K250665) | Konica Minolta, Inc. | 2025-06-17 |
| EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (K243618) | Bridge TO Life | 2025-06-17 |
| Dorado™ PTA Balloon Dilatation Catheter (K250219) | Bard Peripheral Vascular, Inc. | 2025-06-17 |
| RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT (K250440) | Brainlab AG | 2025-06-17 |
| Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (K243880) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |
| VitalSigns 1-Lead Holter (VSH101) (K243003) | VitalSigns Technology Co., Ltd. | 2025-06-17 |
| Integrity™ Implant (K250997) | Anika Therapeutics, Inc. | 2025-06-17 |
| Oxiplex® (DEN240038) | Fziomed, Inc. | 2025-06-17 |
| CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (K251017) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-17 |
| uOmniscan (K243666) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-06-17 |
| Nano-Check Influenza+COVID-19 Dual Test (K243561) | Nano-Ditech Corporation | 2025-06-17 |
| COAPTIUM Connect with TISSIUM LIGHT (DEN240066) | Tissium SA | 2025-06-17 |
| MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K250436) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-06-16 |
| Silicone Urethral Catheter (Silicone Urethral Catheter) (K243011) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 |
| Access hsTnI (K242870) | Beckman Coulter, Inc. | 2025-06-16 |
| BD Veritor System for SARS-CoV-2 (K243872) | Becton, Dickinson and Company | 2025-06-16 |
| Mosaic (V1.0.1) (K244012) | Navier Medical | 2025-06-16 |
| MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile (K250443) | Siemens Healthcare GmbH | 2025-06-16 |
| EvoEndo Single-Use Endoscopy System (K250900) | EvoEndo, Inc. | 2025-06-16 |
| Geo Abutment (K242978) | Geomedi Co,., Ltd. | 2025-06-16 |
| Methinks NCCT Stroke (K250685) | Methinks Software, S.L | 2025-06-16 |
| X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (K251617) | Expanding Innovations, Inc. | 2025-06-16 |
| Bioptimal Bipolar Pacing Catheter (K242863) | Bioptimal International Pte. , Ltd. | 2025-06-15 |
| IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) (K243036) | Bestway Plastic and Metal Products , Ltd. | 2025-06-15 |
| Withings ECG App (K240795) | Withings | 2025-06-15 |
| Accuro® 3S Needle Guide Kit (K250469) | Rivanna Medical, Inc. | 2025-06-13 |
| 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) (K243237) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-06-13 |
| 3 in 1 TENS UNIT (K250759) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 |
| Vessel Sealer Curved (480522) (K250674) | Intuitive Surgical, Inc. | 2025-06-13 |
| BinaxNOW COVID-19 Ag Card (K250273) | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 |
| Medtronic Stedi Extra Support Guidewire (K250075) | Medtronic, Inc. | 2025-06-13 |
| Prismira (K243729) | Lumos Labs, Inc. | 2025-06-13 |
| MV Flow Aspiration Pump (MVFLOWPMP01) (K243638) | Microvention | 2025-06-13 |
| Aventus Thrombectomy System (K251189) | Inquis Medical | 2025-06-13 |
| FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (K244017) | Fujifilm Corporation | 2025-06-13 |
| ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) (K242852) | Inomed Medizintechnik GmbH | 2025-06-13 |
| Mfinity Femoral System (K251166) | Medacta International S.A. | 2025-06-13 |
| Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) (K243633) | Brainlab AG | 2025-06-13 |
| Excipio LV Prime Thrombectomy Device (K251485) | Contego Medical, Inc. | 2025-06-13 |
| Eleganz Fusion Screw System (Fusion Screw System) (K250251) | Dev4 | 2025-06-13 |
| Q-Switched Nd:YAG Laser (SHE-LSP101-1) (K250936) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-06-12 |
| Medical Monitor (32HS710S) (K251209) | Lg Electronics.Inc | 2025-06-12 |
| RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (K251154) | Ht Medical D.B.A. Xenix Medical | 2025-06-12 |
| OneLIF™ Interbody Fusion System (K251459) | Novapproach Spine, LLC | 2025-06-12 |
| GMReis Fibula Nail System (K250559) | Gm Dos Reis Industria E Comercio | 2025-06-12 |
| Disposable Cytology Brush BC-202D/203D Series (K251279) | Olympus Medical Systems Corporation | 2025-06-12 |
| Deka Bluebeam (K243683) | El.En S.P.A. | 2025-06-12 |
| FIX-L PEEK PLIF and T-PLIF System (K243973) | Jeil Medical Corporation | 2025-06-12 |
| iDart Lyme IgM ImmunoBlot Kit (K242872) | Id-Fish Technology, Inc. | 2025-06-12 |
| Bard® Mesh; Bard® Mesh Pre-Shaped (K251557) | Davol, Inc. | 2025-06-12 |
| Multi M Series (K250826) | Dmax Co., Ltd. | 2025-06-12 |
| TRIGEN Stable Lock Nut & Washer (K243608) | Smith & Nephew, Inc. | 2025-06-12 |
| ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856) | Biomérieux | 2025-06-12 |
| Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (K251193) | Medtronic Sofamor Danek, Inc. | 2025-06-12 |
| Aurora (K251153) | Ge Medical Systems Israel | 2025-06-12 |