| K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. Jul 9, 2025 |
| K243500 — ARCHITECT iGentamicin | Abbott Laboratories Jul 9, 2025 |
| K243731 — HEXIM Implant; Samwon General Abutments | P&A USA Jul 9, 2025 |
| K251759 — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | Boston Scientific Corporation Jul 9, 2025 |
| K250505 — EZ-FIDUCIALS | Phasor Health, LLC Jul 9, 2025 |
| K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Basic Medical Technology, Inc. Jul 9, 2025 |
| K250108 — OptiVu Shoulder | Mr Surgical Solutions, LLC Jul 9, 2025 |
| K251520 — Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. Jul 9, 2025 |
| K251766 — TumorSight Viz | SimBioSys, Inc. Jul 8, 2025 |
| K250342 — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Encompass Industries Sdn. Bhd. Jul 8, 2025 |
| K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. Jul 8, 2025 |
| K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. Jul 8, 2025 |
| K251776 — EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. Jul 8, 2025 |
| K250695 — Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. Jul 8, 2025 |
| K251804 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Jul 8, 2025 |
| K251741 — PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. Jul 8, 2025 |
| K241525 — ExcelsiusXR | Globus Medical, Inc. Jul 8, 2025 |
| K250065 — DENSITY; DENZA; DENSITY Noir | Jeisys Medical Incorporated Jul 8, 2025 |
| K251761 — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. Jul 8, 2025 |
| K251502 — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. Jul 7, 2025 |
| K250496 — Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | Zibo Shengkun Chemical Industry Co., Ltd. Jul 7, 2025 |
| K243884 — TAVIPILOT | Caranx Medical Jul 7, 2025 |
| K250827 — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Carlsmed, Inc. Jul 7, 2025 |
| K251863 — CustomSurg OrthoPlanner | Customsurg AG Jul 7, 2025 |
| K250165 — Pastelle | Wontech Co., Ltd. Jul 3, 2025 |
| K243678 — TalisMann Neuromodulation System | Bioventus, LLC Jul 3, 2025 |
| K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. Jul 3, 2025 |
| K250398 — Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. Jul 3, 2025 |
| K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. Jul 3, 2025 |
| K243826 — SMR Reverse HP Shoulder System | Lima Corporate S.P.A. Jul 3, 2025 |
| K250838 — Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. Jul 3, 2025 |
| K251390 — MTA vpt | Voco GmbH Jul 3, 2025 |
| K251528 — syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. Jul 3, 2025 |
| K243123 — IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. Jul 3, 2025 |
| K243679 — MammoScreen® (4) | Therapixel Jul 3, 2025 |
| K250286 — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited Jul 3, 2025 |
| K251599 — Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. Jul 3, 2025 |
| K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific Jul 3, 2025 |
| K243255 — URIS Long Implant & Abutments | Truabutment, Inc. Jul 3, 2025 |
| K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | W&H Dentalwerk Buermoos GmbH Jul 3, 2025 |
| K251080 — IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. Jul 3, 2025 |
| K243220 — Onera STS 2 (ONERA STS 2) | Onera B.V. Jul 3, 2025 |
| K250822 — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. Jul 3, 2025 |
| K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. Jul 3, 2025 |
| K250733 — 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. Jul 3, 2025 |
| K243207 — BD Vacutainer® Eclipse Blood Collection Needle | Becton, Dickinson And Company Jul 3, 2025 |
| K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips | Teleflex Medical Jul 3, 2025 |
| K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation Jul 2, 2025 |
| K250729 — Power Wheelchair (MOB1107) | Vive Health, LLC Jul 2, 2025 |
| K250279 — RC-SwiftPrep | Belport Company, Inc., Gingi-Pak Jul 2, 2025 |