| AEON™ Endoscopic Powered Stapler (K251482) | Lexington Medical, Inc. | 2025-07-11 |
| Disposable Biopsy Needle (K243296) | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) (K250942) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-07-11 |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (K243274) | Centers for Disease Control and Prevention | 2025-07-11 |
| Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (K251786) | Geistlich Pharma AG | 2025-07-11 |
| Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (K241179) | VivaQuant, Inc. | 2025-07-11 |
| BD Cathena™ Safety IV Catheter (K251155) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-11 |
| Ceragem Automatic Thermal Massager (CGM MB-2401) (K250266) | Ceragem Co., Ltd. | 2025-07-11 |
| Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter (K250772) | Surgical Instrument Service and Savings, Inc. | 2025-07-11 |
| CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (K251885) | Providence Medical Technology, Inc. | 2025-07-10 |
| CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072) | Avalign Technologies, Inc. | 2025-07-10 |
| Microcurrent Facial Device (CEC101, EE0101, EEI101) (K244004) | Shenzhen Dachi Communication Co., Ltd. | 2025-07-10 |
| Arthrex PushLock Suture Anchors (K251145) | Arthrex, Inc. | 2025-07-10 |
| Vivid Pioneer (K251169) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-10 |
| RAP Femoral Venous Cannulae (K250283) | LivaNova USA, Inc. | 2025-07-10 |
| ARENA Star, Galaxy Star (K250063) | Arum Dentistry Co., Ltd. | 2025-07-10 |
| Sonosite LX Ultrasound System (K251830) | FUJIFILM Sonosite, Inc. | 2025-07-10 |
| ZBPro Diagnostic (K243252) | Zbeats, Inc. | 2025-07-10 |
| Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (K250032) | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) (K251945) | TriMed, Inc. | 2025-07-10 |
| OptiVu™ Shoulder (K250108) | Mr Surgical Solutions, LLC | 2025-07-09 |
| Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) (K250193) | Basic Medical Technology, Inc. | 2025-07-09 |
| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
| HEXIM Implant; Samwon General Abutments (K243731) | P&A USA | 2025-07-09 |
| HARBOR Occlusion Device (K250133) | Nuvascular, Inc. | 2025-07-09 |
| Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (K251759) | Boston Scientific Corporation | 2025-07-09 |
| Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (K242562) | Ge Medical Systems Information Technologies, Inc. | 2025-07-09 |
| panaSIa SI Fusion System (K250247) | Wenzel Spine, Inc. | 2025-07-09 |
| EZ-FIDUCIALS (K250505) | Phasor Health, LLC | 2025-07-09 |
| Cios Alpha; Cios Flow (K251520) | Siemens Medical Solutions USA, Inc. | 2025-07-09 |
| ExcelsiusXR™ (K241525) | Globus Medical, Inc. | 2025-07-08 |
| Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl (K250342) | Encompass Industries Sdn. Bhd. | 2025-07-08 |
| TumorSight Viz (K251766) | SimBioSys, Inc. | 2025-07-08 |
| DENSITY; DENZA; DENSITY Noir (K250065) | Jeisys Medical Incorporated | 2025-07-08 |
| EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (K251776) | Encore Medical L.P. | 2025-07-08 |
| Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (K251761) | Momentis Surgical , Ltd. | 2025-07-08 |
| Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (K240908) | Spectrum Medical , Ltd. | 2025-07-08 |
| K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (K251447) | Terumo Europe N.V. | 2025-07-08 |
| Single-use Ureteral Access Sheath (K250695) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-07-08 |
| PathLoc Lumbar Interbody Fusion Cage System (K251741) | L&K BIOMED Co., Ltd. | 2025-07-08 |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD (K251804) | S.M.A.I.O | 2025-07-08 |
| Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) (K250496) | Zibo Shengkun Chemical Industry Co., Ltd. | 2025-07-07 |
| TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (K251502) | Life Spine, Inc. | 2025-07-07 |
| CustomSurg OrthoPlanner (K251863) | Customsurg AG | 2025-07-07 |
| 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 (K250827) | Carlsmed, Inc. | 2025-07-07 |
| TAVIPILOT (K243884) | Caranx Medical | 2025-07-07 |
| BD Vacutainer® Eclipse™ Blood Collection Needle (K243207) | Becton, Dickinson and Company | 2025-07-03 |
| Denudation Pipettes (K250838) | Guangzhou Pinzhi Medical Device Co., Ltd. | 2025-07-03 |
| URIS Long Implant & Abutments (K243255) | Truabutment, Inc. | 2025-07-03 |
| Disposable Percutaneous Nephrostomy Dilatation Kit (K250448) | Shenzhen Trious Medical Technology Co., Ltd. | 2025-07-03 |
| syngo.via MI Workflows; Scenium; syngo MBF (K251528) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| Single-use Ureteral Access Sheath (K251599) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-03 |
| MammoScreen® (4) (K243679) | Therapixel | 2025-07-03 |
| TalisMann Neuromodulation System (K243678) | Bioventus, LLC | 2025-07-03 |
| Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (K250286) | The Magstim Company Limited | 2025-07-03 |
| SMR Reverse HP Shoulder System (K243826) | Lima Corporate S.P.A. | 2025-07-03 |
| IPL Treatment Device (MDSQMC-01) (K243123) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 |
| 3DOSE 1ml Syringe (K250733) | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
| Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K251291) | Boston Scientific | 2025-07-03 |
| Pastelle (K250165) | Wontech Co., Ltd. | 2025-07-03 |
| Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (K251671) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| Onera STS 2 (ONERA STS 2) (K243220) | Onera B.V. | 2025-07-03 |
| Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (K250105) | Aveera Medical, Inc. | 2025-07-03 |
| MTA vpt (K251390) | Voco GmbH | 2025-07-03 |
| SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse (K250822) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) (K243280) | W&H Dentalwerk Buermoos GmbH | 2025-07-03 |
| Innovita Flu A/B Antigen Rapid Test (K250398) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025-07-03 |
| Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (K251054) | Teleflex Medical | 2025-07-03 |
| IdentiTi II Cervical Interbody System (K251080) | Alphatec Spine, Inc. | 2025-07-03 |
| OsteoFlo HydroFiber (K251720) | SurGenTec, LLC | 2025-07-02 |
| SurgiLight 1470 Diode Laser System (Model:Halo) (K251049) | Micro-Energy Medical Technology Co., Ltd. | 2025-07-02 |
| Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) (K243468) | Joytech Healthcare Co. , Ltd. | 2025-07-02 |
| Power Wheelchair (MOB1107) (K250729) | Vive Health, LLC | 2025-07-02 |
| CS-Pro MED (K250779) | Curative Sound Therapeutics | 2025-07-02 |
| Orthoscan TAU Mini C-Arm (K250587) | Ziehm-Orthoscan, Inc. | 2025-07-02 |
| AuroLase® System (K243701) | Nanospectra Biosciences, Inc. | 2025-07-02 |
| G0 Blood Pressure Monitoring System (G0) (K250415) | Aktiia SA | 2025-07-02 |
| Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (K250312) | Medline Industries, LP | 2025-07-02 |
| Pure Impact (K251746) | Sofwave Medical, Ltd. | 2025-07-02 |
| 8 mm Assist Cannula; 12 mm Assist Cannula (K251490) | Intuitive Surgical, Inc. | 2025-07-02 |
| Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K243868) | Pegavision Corporation | 2025-07-02 |
| EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (K251241) | Encore Medical L.P. | 2025-07-02 |
| Mendaera Guidance System (K250524) | Mendaera, Inc. | 2025-07-02 |
| Boehringer Laboratories Liver Retractor (K243399) | Boehringer Laboratories, LLC | 2025-07-02 |
| Identity Shoulder System (K250848) | Zimmer, Inc. | 2025-07-02 |
| Electric Wheelchair (HG-630) (K251285) | Zhejiang Automwheel Tech Co., Ltd. | 2025-07-02 |
| OPUSWAVE Dual Sensor Imaging System (K250684) | Terumo Cardiovascular Systems Thi Plant | 2025-07-02 |
| Fiber Laser Treatment Systems (HS-232,HS-233) (K251031) | Shanghai Apolo Medical Technology Co., Ltd. | 2025-07-02 |
| RC-SwiftPrep (K250279) | Belport Company, Inc., Gingi-Pak | 2025-07-02 |
| Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (K250391) | Elekta Solutions AB | 2025-07-02 |
| Felix NeuroAI System (K250096) | Fasikl Incorporated | 2025-07-01 |
| Momentum® Posterior Spinal Fixation System (K251719) | Ulrich Medical USA, Inc. | 2025-07-01 |
| Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (K250699) | Convatec | 2025-07-01 |
| Bunkerhill Abdominal Aortic Quantification (AAQ) (K243779) | BunkerHill Health | 2025-07-01 |
| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| droplet® personal lancets (K250016) | Htl-Strefa S.A | 2025-07-01 |
| StrokeSENS ASPECTS Software Application (K250221) | Circle Cardiovascular Imaging, Inc. | 2025-07-01 |
| SonoMSK (K243690) | PAJUNK GmbH Medizintechnologie | 2025-07-01 |
| Arthrex iBalance Partial Knee System (K251453) | Arthrex, Inc. | 2025-07-01 |
| MiniMed 780G insulin pump (K251032) | Medtronic Minimed, Inc. | 2025-07-01 |