510(k) Clearances — Page 165

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 165 of 3,525)
ClearancesDetails
K232682 — Pre-Sintered Zirconia Coloring LiquidChengdu Besmile Medical Technology Co., Ltd. Mar 19, 2024
K231719 — Medical Surgical MaskAzur Medical Company, Inc. Mar 19, 2024
K240668 — Amydi-med Disposable Non-invasive EEG electrodesShenzhen Amydi-Med Electrics Tech Co., Ltd. Mar 19, 2024
K231843 — ARX Viral Transport Media Collection and Transport SystemArx Sciences, Inc. Mar 19, 2024
K240515 — uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc. Mar 18, 2024
K233599 — X-Clever (ASHK100G)Lg Electronics.Inc Mar 18, 2024
K240113 — CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc. Mar 18, 2024
K240139 — Real Intelligence™ CORI™Blue Belt Technologies, Inc. Mar 18, 2024
K233660 — nCommand Lite SystemIonic Health Mar 18, 2024
K230981 — Meriglu Topical Skin AdhesiveM/S. Meril Endo Surgery Private Limited. Mar 16, 2024
K240466 — STARband 3DOrthomerica Products, Inc. Mar 15, 2024
K233748 — CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc. Mar 15, 2024
K234115 — APRO 55 CatheterAlembic, LLC Mar 15, 2024
K240112 — Light Cure CompositeSincera Technology (Changchun) Co., Ltd. Mar 15, 2024
K232327 — EndorailEndostart S.R.L. Mar 15, 2024
K230802 — Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd. Mar 15, 2024
K231856 — TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd Mar 15, 2024
K233814 — 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)3M Company Mar 15, 2024
K240694 — FORMA Composite (Shade A3D)Ultradent Products, Inc. Mar 15, 2024
K240117 — Aventus Thrombectomy System (IM-2001/IM-0002)Inquis Medical Mar 15, 2024
K233986 — BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)Becton, Dickinson And Company Mar 15, 2024
K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek Mar 15, 2024
K233799 — Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)Shenzhen Yuezhongxing Technology Co., Ltd. Mar 15, 2024
K240454 — RESPONDER® Polysaccharide HemostatStarch Medical, Inc. Mar 15, 2024
K233342 — CINA-ASPECTSAvicenna.Ai Mar 15, 2024
K232234 — Nouvo Safety SetPoly Medicure Limited Mar 15, 2024
K234104 — PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd. Mar 15, 2024
K233747 — Concha Sol Hearing Aids (CL-1001)Concha Labs Mar 15, 2024
K240539 — Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) Mar 15, 2024
K233307 — Intensity Pulsed Light Therapy SystemBeijing Adss Development Co., Ltd. Mar 15, 2024
K240430 — Otoport ProOtodynamics, Ltd. Mar 15, 2024
K233881 — ivWatch® Model 400Ivwatch, LLC Mar 15, 2024
K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc. Mar 14, 2024
K231529 — CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc. Mar 14, 2024
K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationIntuitive Surgical, Inc. Mar 14, 2024
K233853 — LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. Mar 14, 2024
K232980 — SpermAlign Sperm Separation DeviceCytoswim, Ltd. Mar 14, 2024
K231850 — QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc. Mar 14, 2024
K232567 — Myriad SPECTRA Light SourceNico Corporation Mar 14, 2024
K233542 — Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance SystemStryker Leibinger GmbH & Co KG Mar 14, 2024
K232301 — Define RF Microneedling SystemAesthetic Management Partners Mar 14, 2024
K233958 — hekaDrillZethon, Ltd. Mar 14, 2024
K233968 — CINA-iPEAvicenna.Ai Mar 13, 2024
K234008 — CERAMENT GBonesupport AB Mar 13, 2024
K234002 — ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific Mar 13, 2024
K233070 — Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)Chongqing Rob Linka Science And Technology Co., Ltd. Mar 13, 2024
K233136 — Hygeia Express Powered Breast PumpHygeia II Medical Group, Inc. Mar 13, 2024
K234055 — DEKA LoopDeka Research And Development Mar 13, 2024
K233952 — DEKA ACE Pump SystemDeka Research And Development Mar 13, 2024
K233949 — ACCORD Cable SystemSmith & Nephew, Inc. Mar 13, 2024
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