510(k) Clearances

174,759 clearances total

K240420 — NeuroField Analysis SuiteNeurofield, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234129 — Ecomed Disposable Administration SetsEcomed Solutions, LLC Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242223 — SuperSonic HepaVuSupersonic Imagine Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242650 — zLOCK Lumbar Facet Fixation SystemZygofix , Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242504 — Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240604 — MTONE EVO (MTONE EVO)M&T S.R.L. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240722 — Derma-R Cream (Derma-R Cream)Raya Pharmaceuticals, LLC Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241332 — aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233153 — Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240036 — PIUR tUS InfinityPiur Imaging GmbH Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232670 — HiCardi+ H100MEZOO Co., Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242509 — HAnano InterFuse(R) Modular InterbodyNext Orthosurgical Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242162 — Coconut HybridGood Clean Love, Inc. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234096 — MonoStereoMedicaltek Co., Ltd. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242167 — Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240183 — Star E900 Handpiece SeriesDentalez, Inc., Stardental Division Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241709 — Pectus Blu Support Bar SystemBiomet Microfixation Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242478 — GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241465 — Midas Flowmeter; eAVSParker Hannifin Corporation Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240901 — StethophoneSparrow Acoustics, Inc. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)Terragene S.A. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241123 — Perpak™ Sterilization Tyvek PouchKm Corp. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233064 — Copra SupremeWhitepeaks Dental Solutions GmbH Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234153 — EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)Edgelife Technologies, LLC Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231893 — LOWTEM Crystal 120Lowtem Co., Ltd. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241769 — Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241784 — Arrow® Nitinol WireTeleflex Medical Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241424 — InnoCare Specialty Foley CatheterInnocare Urologics, LLC Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240293 — STSTechbopulm, Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240250 — 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240689 — Robin's EggTelebrands Corporation Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233721 — KLS Martin Drill-Free MMF ScrewKLS-Martin L.P. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241942 — TriMed Bridge PlatesTriMed, Inc. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234132 — Medline Reusable Sterilization WrappersMedline Industries, LP Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242186 — Neo Sculptor (OF-NEO001)Ofan Intelligent Technology (Guangzhou) Co. , Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008Togo Medikit Co., Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240660 — Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeKulzer, LLC Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240373 — Air compression Leg Massager (MM0520, MM0521, MM0522)Zhangzhou Easepal Medical Science and Technology Co., Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240274 — PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241771 — Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234089 — DNA ApplianceVivos Therapeutics Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240638 — Power Wheelchair (YH-E7007)Ningbo Youhuan Automation Technology Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241762 — OneMarkView Point Medical Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232938 — Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234050 — HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization WrapO&M Halyard, Inc. Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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