510(k) Clearances — Page 164

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 164 of 3,525)
ClearancesDetails
K232322 — MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc. Mar 22, 2024
K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5Oxoid Limited (Part Of Thermo Fisher Scientific) Mar 22, 2024
K240540 — uMR OmegaShanghai United Imaging Healthcare Co., Ltd. Mar 22, 2024
K231938 — Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric AcidO&M Halyard, Inc. Mar 22, 2024
K231953 — Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)Coloplast Corp. Mar 22, 2024
K231795 — QuickVue COVID-19 TestQuidel Corporation Mar 22, 2024
K240715 — Idys® C ZP 3DTiClariance Mar 22, 2024
K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc. Mar 22, 2024
K233569 — SeptAlignSpirair, Inc. Mar 22, 2024
K233441 — The Vest APX System (PVAPX1)Baxter Healthcare Corportation Mar 22, 2024
K232548 — Corsano CardioWatch 287-2 SystemCorsano Health B.V. Mar 22, 2024
K233713 — Pilling Tracheostomy TubesTeleflex Medical Mar 22, 2024
K240522 — Esophageal TTS StentTaewoong Medical Mar 22, 2024
K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC Mar 21, 2024
K240530 — DynaNail Mini Tapered HybridMedShape, Inc. Mar 21, 2024
K234081 — RedDrop ONE (One)Reddrop DX Mar 21, 2024
K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemDePuy Synthes Mar 21, 2024
K240179 — Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. Mar 21, 2024
K240253 — Reach NeedleAerin Medical, Inc. Mar 21, 2024
K240309 — Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc. Mar 21, 2024
K230088 — Ankle Truss System (ATS)4Web Medical, Inc. Mar 21, 2024
K240122 — Normatec EliteNormaTec Industries, LP Mar 21, 2024
K232439 — Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd. Mar 21, 2024
K240754 — N2Megagen Implant Co., Ltd. Mar 21, 2024
K234062 — APTUS Hand Scaphoid PlatesMedartis AG Mar 21, 2024
K233753 — AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH Mar 21, 2024
K233926 — accufitMettler Electronics Corporation Mar 21, 2024
K232568 — IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation Mar 21, 2024
K234006 — AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl TestAllsource Screening Solutions Mar 21, 2024
K240743 — Peak Universal BondUltradent Products, Inc. Mar 20, 2024
K233642 — InMode RF SystemInMode , Ltd. Mar 20, 2024
K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerWenzhou Longwan Medical Device Factory Mar 20, 2024
K233002 — BEED 2,5, BEED 3,8Excelsior Resources, LLC Mar 20, 2024
K240574 — BruxZir® RadiantPrismatik Dentalcraft, Inc. Mar 20, 2024
K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH Mar 20, 2024
K232654 — Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)Nephron Nitrile, LLC Mar 20, 2024
K240537 — SMARTXIDE PROEl.En S.P.A. Mar 20, 2024
K233375 — Tranquil-L Interbody SystemNexus Spine, LLC Mar 20, 2024
K231974 — PATHFAST®hs-cTnI-IIPhc Corporation Mar 20, 2024
K240507 — NuVasive AttraX ScaffoldNuvasive, Inc. Mar 20, 2024
K234047 — Automatic RegistrationBrainlab AG Mar 20, 2024
K234049 — Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG Mar 20, 2024
K234052 — Access FerritinBeckman Coulter, Inc. Mar 20, 2024
K232125 — V-PVPVitromed GmbH Mar 20, 2024
K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)Shenzhen Desida Technology Co., Ltd. Mar 20, 2024
K234130 — Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OGe Medical Systems Information Technologies, Inc. Mar 20, 2024
K232619 — MATRIX HA PEEK Cervical IBF SystemSapphire Medical Group Mar 19, 2024
K233146 — Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd. Mar 19, 2024
K233772 — Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd. Mar 19, 2024
K234024 — HWJECT Auto-disable syringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Mar 19, 2024
← Previous Page 164 of 3525 Next →