510(k) Clearances — Page 135

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 135 of 3,525)
ClearancesDetails
K240411 — uAI PortalShanghai United Imaging Intelligence Co., Ltd. Sep 6, 2024
K231667 — Withings Sleep RxWithings Sep 6, 2024
K232543 — MSC SFMYocon Biology Technology Company Sep 6, 2024
K240600 — SafeCross Vascular Introducer System (4001)East End Medical I, LLC Sep 6, 2024
K232996 — Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO , Ltd. Sep 6, 2024
K241427 — Access SyphilisBeckman Coulter, Inc. Sep 6, 2024
K234035 — COSINE™ SpacerGlobus Medical, Inc. Sep 6, 2024
K241552 — MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC Sep 6, 2024
K241693 — FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. Sep 6, 2024
K241579 — DD Hybridlayer (multicolored zirconia)Dental Direkt GmbH Sep 6, 2024
K233921 — Luvis Chair (LC700C)Dentis Co., Ltd. Sep 6, 2024
K233806 — T2 PlusOsstem Implant Co., Ltd. Sep 6, 2024
K240203 — URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)Dyne Medical Group, Inc. Sep 5, 2024
K242390 — Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation Sep 5, 2024
K241721 — Electric wheelchair (N3901)Zhejiang Richall Medical Technology Co., Ltd. Sep 5, 2024
K241605 — Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyNanovis, LLC Sep 5, 2024
K241723 — Electric wheelchair (W3902)Zhejiang Richall Medical Technology Co., Ltd. Sep 5, 2024
K231566 — ICX-Implant SystemMedentis Medical GmbH Sep 5, 2024
K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030Prestige Ameritech Sep 5, 2024
K241356 — Fine Osteotomy™Bodycad Laboratories, Inc. Sep 5, 2024
K241155 — Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd. Sep 5, 2024
K233998 — TRAQinform IQAiq Global, Inc. Sep 5, 2024
K232692 — Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)Intradin (Shanghai) Machinery Co., Ltd. Sep 5, 2024
K240142 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFujifilm Corporation Sep 4, 2024
K231502 — Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi Sep 4, 2024
K240158 — Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. Sep 4, 2024
K233977 — VelacurSonic Incytes Sep 4, 2024
K231095 — Tamper Evident CapInternational Medical Industries, Inc. Sep 4, 2024
K221275 — Qraycam PROAIOBIO Co., Ltd. Sep 4, 2024
K242305 — BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A. Sep 4, 2024
K241071 — NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. Sep 4, 2024
K240646 — DreamClearSomnomed Technologies Inc., Doing Business AS Remware Sep 4, 2024
K242306 — SignalNED System (Model RE)Forest Devices, Inc. Sep 4, 2024
K240487 — EVOS Patella PlatesSmith & Nephew Sep 3, 2024
K242069 — Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine Sep 3, 2024
K242251 — Litho 60; Litho 100; Litho 150Quanta System Spa Sep 3, 2024
K242319 — Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc. Sep 3, 2024
K241295 — SOMATOM On.siteSiemens Medical Solutions USA, Inc. Sep 3, 2024
K233805 — K5Osstem Implant Co., Ltd. Chair Business Sep 3, 2024
K241611 — ShapeIT (SI014135)Imds Operations B.V. Sep 3, 2024
K241592 — Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. Aug 31, 2024
K233872 — DaylightBig Health, Inc. Aug 30, 2024
K241148 — Salto Talaris Ankle PSI System3D Systems, Inc. Aug 30, 2024
K234027 — embecta Insulin Delivery SystemEmbecta Medical I, LLC Aug 30, 2024
K242275 — syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. Aug 30, 2024
K241393 — ODI-TechOdi Medical AS Aug 30, 2024
K241602 — Kingcera Dental Zirconia BlankHunan Qinghao Puzhong Technology Co., Ltd. Aug 30, 2024
K240180 — Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. Aug 30, 2024
K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMVBoston Scientific Aug 30, 2024
K233932 — Alinity i Toxo IgMAbbott Laboratories Aug 30, 2024
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