510(k) Clearances in 2023 — Page 31

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 31 of 67)
510(k) clearancesDetails
K231620 — Nuubo SmartSmart Solutions Technologies SL Aug 1, 2023
K231959 — EXPD 4357; EXPD 4357PDRTECH Corporation Aug 1, 2023
K231963 — REAL INTELLIGENCE™ CORI™Blue Belt Technologies, Inc. Aug 1, 2023
K230162 — uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. Aug 1, 2023
K230873 — Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. Aug 1, 2023
K231954 — Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc. Aug 1, 2023
K231591 — V-Print c&b tempVoco GmbH Jul 31, 2023
K230956 — BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / Jul 31, 2023
K231613 — Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.Zhuzhou Goldenhot Medical Technology Co., Ltd. Jul 31, 2023
K232088 — Altris IMSAltris, Inc. Jul 31, 2023
K230004 — Disposable HemoclipYangzhou Fartley Medical Instrument Technology Co., Ltd. Jul 31, 2023
K231321 — Nooance Led And Laser HelmetShenzhen Kaiyan Medical Equipment Co., Ltd. Jul 31, 2023
K230630 — ZENEX Implant System_NarrowIzenimplant Co., Ltd. Jul 31, 2023
K231698 — AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. Jul 31, 2023
K230858 — QUATERA 700Carl Zeiss Meditec, AG Jul 31, 2023
K223567 — CNS-2101 Central MonitorNihon Kohden Corporation Jul 31, 2023
K221767 — Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd. Jul 31, 2023
K223097 — RenaNav Ureteroscope SystemCenterPoint Systems, LLC Jul 31, 2023
K222862 — SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd. Jul 30, 2023
K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax Of America, Inc. Jul 28, 2023
K231589 — Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD. Jul 28, 2023
K231931 — Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd. Jul 28, 2023
K231618 — 3 Layer Surgical Mask (134252531)Original Mattress Factory, Inc. Jul 28, 2023
K222794 — FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG Jul 28, 2023
K222735 — HJY VisualNext Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. Jul 28, 2023
K231480 — Bright MTA Sealer PlusGenoss Co., Ltd. Jul 28, 2023
K222587 — PatCom Distal Chip EndoscopeH&A Mui Enterprises, Inc. Jul 28, 2023
K223710 — i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point Of Care, Inc. Jul 28, 2023
K222902 — Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc. Jul 28, 2023
K230898 — FLUOBEAM® LX RedFluoptics Sas Jul 28, 2023
K230801 — Pathfinder Endoscope Overtube with Balloon DeviceNeptune Medical, Inc. Jul 28, 2023
K223781 — Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation Jul 28, 2023
K231073 — SkinStylus SteriLock® MicroSystem, Model Number MP1209SLEsthetic Medical, Inc. Jul 28, 2023
K231951 — SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC Jul 28, 2023
K230813 — BlueStar and BlueStar RxWelldoc, Inc. Jul 28, 2023
K223670 — MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development Of Medical Devices, Ltd.; Mesi D.O.O. Jul 28, 2023
K231313 — Therapy Mask 3100 NC/SPRespironics, Inc. Jul 28, 2023
K231552 — Dia-CemDiaDent Group International Jul 28, 2023
K231195 — Brainomix 360 Triage ICHBrainomix Limited Jul 27, 2023
K231261 — Altaviz Needle Kit IIAltaviz, LLC Jul 27, 2023
K231886 — SURGIVISIO DeviceEcential Robotics Jul 27, 2023
K223591 — cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. Jul 27, 2023
K212077 — Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. Jul 27, 2023
K231236 — IBS-B MIS Beveled Screw SystemIn2Bones USA, LLC Jul 27, 2023
K230838 — Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument PocketsCardinal Health200, LLC Jul 27, 2023
K231555 — LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd. Jul 27, 2023
K231223 — MDx-Chex for BC-GNStreck Jul 27, 2023
K230074 — Rapid Aneurysm Triage and NotificationIschemaview, Inc. Jul 27, 2023
K231044 — R2P NavicrossTerumo Medical Corporation Jul 27, 2023
K231912 — Therm-XZenith Technical Innovations Jul 27, 2023
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