510(k) Clearances — Page 113

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 113 of 3,525)
ClearancesDetails
K241273 — FullFocusPaige.Ai, Inc. Jan 9, 2025
K242805 — Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd. Jan 9, 2025
K242290 — DormoTech NLabDormotech Medical, Ltd. Jan 8, 2025
K241003 — HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc. Jan 8, 2025
K242842 — ANNE View, Central HubSibel Health, Inc. Jan 8, 2025
K240590 — Electrical Scooter, WT-T4SUW'U'S Tech Co., Ltd. Jan 8, 2025
K243813 — QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH Jan 8, 2025
K241806 — Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelLife Technologies Corporation Jan 8, 2025
K242661 — TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG Jan 8, 2025
K243818 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)Hartalega NGC Sdn. Bhd. Jan 8, 2025
K243644 — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd. Jan 8, 2025
K242741 — ACE CannulaAce Medical Industry Co., Ltd. Jan 8, 2025
K241489 — ReminGelInter-Med, Inc. Jan 8, 2025
K242043 — Sperm Freezing MediumGimbo Medical Technology Shenzhen Co., Ltd. Jan 8, 2025
K241808 — ApolloHipX (THR.SS.0001)Corin U.S.A. Limited Jan 7, 2025
K243335 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Jan 7, 2025
K242019 — GXR-Series Diagnostic X-Ray SystemDRGEM Corporation Jan 7, 2025
K241456 — GlutenID Celiac Genetic Health Risk TestTargeted Genomics, LLC Jan 7, 2025
K243259 — MASADA Modular Spinal Fixation SystemAstura Medical Jan 7, 2025
K241079 — uCT 780Shanghai United Imaging Healthcare Co., Ltd. Jan 7, 2025
K242588 — COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd. Jan 7, 2025
K242488 — Soteria E-ViewOmega Medical Imaging, LLC Jan 6, 2025
K242123 — Brainomix 360 e-CTABrainomix Limited Jan 6, 2025
K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd. Jan 6, 2025
K243466 — Conformity Stem Extension Line, #0United Orthopedic Corporation Jan 6, 2025
K242760 — WHILL Model RWhill, Inc. Jan 6, 2025
K243481 — TMINI Miniature Robotic SystemTHINK Surgical, Inc. Jan 6, 2025
K242753 — SD TL Implant SystemArum Dentistry Co., Ltd. Jan 6, 2025
K241904 — DermiSphere Dermal TemplateFesariustherapeutics, Inc. Jan 6, 2025
K242139 — Mobility Scooter (YL-09B, YL-07)Yongkang Yile Vehicle Co., Ltd. Jan 6, 2025
K242726 — Synapsys VHITInventis S.R.L. Jan 3, 2025
K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax Of America, Inc. Jan 3, 2025
K242119 — INNOVISION-EXIIDk Medical System Jan 3, 2025
K241757 — syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. Jan 3, 2025
K243737 — Inbella RF SystemInbella Medical, Inc. Jan 3, 2025
K233419 — GBR SystemProimtech Saglik Urunleri Anonim Sirketi Jan 3, 2025
K240346 — NobelProcera Zirconia Implant BridgeNobel Biocare AB Jan 3, 2025
K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point Of Care, Inc. Jan 3, 2025
K233118 — DUET-V (Model: ESK-3261DV)Eunsung Global Corp Jan 3, 2025
K242578 — EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC Jan 3, 2025
K243363 — JLK-ICHJLK, Inc. Jan 3, 2025
K241283 — Elemental GranulateZinkh NV Jan 3, 2025
K241350 — Clarify DLGe Medical Systems Israel, Functional Imaging Jan 3, 2025
K250015 — Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation Jan 3, 2025
K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl Jan 2, 2025
K243049 — Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd. Jan 2, 2025
K242448 — Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)Anhui Jbh Medical Apparatus Co., Ltd. Jan 2, 2025
K241568 — CrystLCare™ PRO Biorestorative, Fluoride-PlusGreenMark Biomedical, Inc. Jan 2, 2025
K242789 — Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd. Jan 2, 2025
K242334 — Ezra FlashEzra Ai, Inc. Jan 2, 2025
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