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PMN records

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd2026-09-06
K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.2026-09-06
K261684FreezeSpray TACryosurgery, Inc.2026-09-05
K254135LipoSurg ARTISTNOUVAG AG2026-09-05
K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-09-04
K262292Gastric AlimetryAlimetry , Ltd.2026-09-04
K26227770 NeuGlide CatheterPiraeus Medical, Inc.2026-09-04
K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)Medtronic Xomed, Inc.2026-09-04
K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.2026-09-04
K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC2026-09-04
K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.2026-09-04
K261057ActivaScrew™ Cannulated COMBioretec, Ltd.2026-09-04
K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,2026-09-04
K260525NextMR SpineMRI2CT, Inc.2026-09-04
K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Siemens Healthcare Diagnostics Products, Ltd.2026-09-04
K260035Digital Indeflator INFLANTEUAB Telemedicina2026-09-04
K254264Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)2026-09-04
K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)2026-09-04
K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.2026-09-04
K253836FCT iStream Phase 2Fujifilm Corporation2026-09-04
K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.2026-09-04
K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.2026-09-03
K262460Rezum SystemBoston Scientific2026-09-03
K262315NeuroBlate SystemMonteris Medical2026-09-03
K262243Profisil FreeKettenbach GmbH & Co. KG2026-09-03
K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering2026-09-03
K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical2026-09-03
K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.2026-09-03
K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.2026-09-03
K260503Triton 1 SystemNeptune Medical, Inc.2026-09-03
K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro2026-09-03
K254000Happy Health Blood Pressure MonitorHappy Health, Inc.2026-09-03
K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.2026-09-03
K253673M•care System (MW-20)Marani Health, Inc.2026-09-03
K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.2026-09-03
DEN250044STEMI AI ECG ModelPowerful Medical, Inc.2026-09-03
K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC2026-09-02
K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical2026-09-02
K262364Ellian Enigma RF DeviceEllian Corp2026-09-02
K262153Pivot Insulin Delivery SystemModular Medical, Inc.2026-09-02