510(k) Clearances — Page 171

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 171 of 3,525)
ClearancesDetails
K234037 — CATS-L Tonometer™ PrismCats Tonometer, LLC Feb 9, 2024
K232072 — AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18GH.S Hospital Service S.P.A Feb 9, 2024
K240098 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation Feb 9, 2024
K231733 — Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies , Ltd. Feb 9, 2024
K233631 — ZapStim Controller Application (Z1023)Revital Lab, Inc. Feb 9, 2024
K234034 — VenaCore Thrombectomy Catheter (46-101)Inari Medical, Inc. Feb 9, 2024
K240084 — V-STRUT® Vertebral ImplantHyprevention Feb 9, 2024
K232854 — Leksell GammaPlan (LGP)Elekta Solutions AB Feb 8, 2024
K231536 — eQUANT SystemAvails Medical, Inc. Feb 8, 2024
K233024 — Alma HarmonyAlma Lasers, Inc. Feb 8, 2024
K232644 — neuro42 MRI SystemNeuro42, Inc. Feb 8, 2024
K231662 — Aid-UIaid Feb 8, 2024
K233914 — XVbeam2000Shenzhen Xpectvision Technology Co., Ltd. Feb 8, 2024
K231575 — Vecttor VT-300Artaflex, Inc. Feb 8, 2024
K230839 — Concentriq DxProscia, Inc. Feb 8, 2024
K233080 — HealthFLDNano-X AI , Ltd. Feb 8, 2024
K240069 — Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)Endolumik Feb 8, 2024
K233476 — Z1 Hip SystemOrchard Medical Development Feb 8, 2024
K233504 — Lexa MINI (RIS-303, RIS-305)W&H Sterilization S.R.L. Feb 8, 2024
K231913 — T-FITTechwin Co., Ltd. Feb 8, 2024
K233184 — T2Bacteria® PanelT2Biosystems, Inc. Feb 8, 2024
K233350 — SINC Support CatheterReflow Medical, Inc. Feb 8, 2024
K233480 — Access SHBGBeckman Coulter, Inc. Feb 8, 2024
K240086 — Ion 3DSurGenTec, LLC Feb 8, 2024
K240075 — FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation Feb 7, 2024
K240064 — Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd. Feb 7, 2024
K232764 — Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateEco Medi Glove Sdn. Bhd. Feb 7, 2024
K232171 — Purema® H Hemoconcentrator (EtO Sterilized)Tecnoideal America Feb 7, 2024
K231956 — F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd. Feb 7, 2024
K233416 — Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd Feb 6, 2024
K233897 — 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)Shenzhen Beacon Display Technology Co., Ltd. Feb 6, 2024
K233115 — Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC Feb 6, 2024
K233960 — INNOVERSE Spinal SystemInnosys Co., Ltd. Feb 6, 2024
K233593 — MAGEC Spinal Bracing and Distraction SystemNuvasive Specialized Orthopedics, Incorporated Feb 6, 2024
DEN230041 — Sleep Apnea FeatureSamsung Electronics Co., Ltd. Feb 6, 2024
K232057 — BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG Feb 6, 2024
K233221 — Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Metro Optics Of Austin, Inc. Feb 6, 2024
K233600 — Smart Fit Knee 3.0TPhilips Healthcare (Suzhou) Co., Ltd. Feb 5, 2024
K232363 — Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc. Feb 5, 2024
K234075 — Flow-NailFlow-Fx, LLC Feb 5, 2024
K232694 — Central Monitoring System (MFM-CMS)Edan Instruments, Inc. Feb 5, 2024
K234013 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc. Feb 5, 2024
K233174 — FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamAssure Tech. (Hangzhou) Co, Ltd. Feb 5, 2024
K233895 — EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);Edwards Lifesciences Feb 5, 2024
K232379 — PREVENT KitClear Choice Therapeutics Feb 5, 2024
K240099 — Ziehm Vision RFDZiehm Imaging GmbH Feb 5, 2024
K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation Feb 4, 2024
K232210 — X-trodes System MX-Trodes Feb 4, 2024
K240030 — Indigo® Aspiration System - Lightning® FlashPenumbra, Inc. Feb 2, 2024
K231534 — 5008X Hemodialysis SystemFresenius Medical Care Feb 2, 2024
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