510(k) Clearances — Page 137

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 137 of 3,525)
ClearancesDetails
K240270 — Electric wheelchair (S7018)Guangdong Prestige Technology Company Limited Aug 27, 2024
K241354 — Sealer SolventInter-Med, Inc. Aug 27, 2024
K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd. Aug 27, 2024
K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG Aug 26, 2024
K240982 — DESS Dental Smart SolutionsTerrats Medical SL Aug 26, 2024
K241538 — TriClip Steerable Guide CatheterABBOTT MEDICAL Aug 26, 2024
K242044 — FiAPC plus probesErbe Elektromedizin GmbH Aug 26, 2024
K241777 — SmartAdjust™ TechnologyInsulet Corporation Aug 26, 2024
K241607 — MyoStrain (6.0)Myocardial Solutions, Inc. Aug 26, 2024
K240286 — PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc. Aug 26, 2024
K241858 — BARS Set (100.60)Ovesco Endoscopy AG Aug 26, 2024
K242202 — LightWalker Laser System FamilyFotona D.O.O. Aug 23, 2024
K241780 — Cardinal Health Nitrile Exam GlovesCardinal Health200, LLC Aug 23, 2024
K241302 — SonoSyncSamsung Medison Co., Ltd. Aug 23, 2024
K240318 — SITTER 3.5mm Versatile SystemBonebridge AG Aug 23, 2024
K241492 — Guided Surgery Kit CasesJJGC Indústria E Comércio De Materiais Dentários S.A. Aug 23, 2024
K233358 — SCoV-2 Ag Detect Rapid TestInBios International, Inc. Aug 23, 2024
K242169 — Morph DNA Steerable Introducer SheathBiocardia Aug 23, 2024
K242264 — TMINI Miniature Robotic SystemTHINK Surgical, Inc. Aug 23, 2024
K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation Aug 23, 2024
K231100 — Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment ScrewProimtech Saglik Urunleri Anonim Sirketi Aug 23, 2024
K240896 — ONE Nitrile CondomGlobal Protection Corp. Aug 23, 2024
K242191 — SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America Aug 23, 2024
K240790 — Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd. Aug 23, 2024
K240593 — VEEGix EEG SystemNeuroServo, Inc. Aug 23, 2024
K233829 — Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)Fisher And Paykel Healthcare Limited Aug 23, 2024
K241803 — INSULCLOCK® v2.0 PROInsulcloud S.L. Aug 22, 2024
K241804 — TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. Aug 22, 2024
K242248 — Introducer Sheath KitsBeijing Demax Medical Technology Co.,Ltd Aug 22, 2024
K241098 — NeuroQuantCortechs Labs, Inc. Aug 22, 2024
K242126 — I.V. Administration SetBq Plus Medical Co., Ltd. Aug 22, 2024
K241979 — Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd Aug 22, 2024
K240227 — LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps Aug 22, 2024
K234128 — Phantom Fibula Nail SystemParagon 28, Inc. Aug 22, 2024
K234076 — iCare ALTIUS CWCentervue S.P.A. Aug 22, 2024
K230071 — Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail SystemTdm Co., Ltd. Aug 22, 2024
K241109 — Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd. Aug 22, 2024
K241369 — LIJIA Night GuardLijia, LLC Aug 22, 2024
K241351 — Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd. Aug 21, 2024
K242141 — TiLink-P SI Joint Fusion SystemSurGenTec, LLC Aug 21, 2024
K242066 — iSage RxAmalgam Rx, Inc. Aug 21, 2024
K240298 — Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. Aug 21, 2024
K240314 — MULA (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd. Aug 21, 2024
K241061 — VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical Aug 21, 2024
K232415 — Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation Aug 21, 2024
K233566 — Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc. Aug 21, 2024
K240859 — Glidewire GT-RTerumo Corporation Aug 21, 2024
K240290 — AiMIFY (1.x)Subtle Medical, Inc. Aug 21, 2024
K242142 — Fraxel® FTX Laser SystemSolta Medical Aug 21, 2024
K233391 — cCeLL - In vivoVPIX Medical, Inc. Aug 21, 2024
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