510(k) Clearances — Page 157

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 157 of 3,525)
ClearancesDetails
K232902 — EVA15 insufflatorPalliare , Ltd. May 2, 2024
K233857 — Neodent Implant System – Custom AbutmentsJJGC Indústria E Comércio De Materiais Dentários S.A. May 2, 2024
K232464 — VereSee Optical Veres Needle SystemFreyja Healthcare, LLC May 2, 2024
K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video BoxMedimaging Integrated Solution, Inc (Miis) May 1, 2024
K240829 — AuST Steerable SheathCenterPoint Systems, LLC May 1, 2024
K233513 — Remex Spine Surgery Navigation System IIRemex Medical Corp. May 1, 2024
K232858 — ORskin BlueMegabay S.A. May 1, 2024
K240882 — BruxZir® EstheticPrismatik Dentalcraft, Inc. May 1, 2024
K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc. May 1, 2024
K231722 — SmarToothSmartooth Co., Ltd. May 1, 2024
K240925 — DuraGraft Vascular Conduit SolutionMarizyme May 1, 2024
K240900 — HOTWIRE™ RF GuidewireAtraverse Medical May 1, 2024
K233284 — Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd. May 1, 2024
K232370 — Percutaneous Nephroscope SystemKarl Storz SE & CO. KG May 1, 2024
K240986 — Cold CompressionJkh Health Co., Ltd. May 1, 2024
K240279 — VIDAS TBI (GFAP, UCH-L1)bioMerieux, Inc. May 1, 2024
K233203 — Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc. May 1, 2024
K232528 — Protective CapNeobiotech Co., Ltd. Apr 30, 2024
K232923 — Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc. Apr 30, 2024
K233403 — Flexset SystemZeto, Inc. Apr 30, 2024
K240118 — Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd. Apr 30, 2024
K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)Physio-Control, Inc. Apr 30, 2024
K232889 — METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd. Apr 30, 2024
K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)Litu Tech , Ltd. Apr 30, 2024
K233231 — Dental Implants and AbutmentsDitron Dental, Ltd. Apr 30, 2024
K240621 — Morpheus® Moldable; Agilon® MoldableBiogennix, LLC Apr 30, 2024
K240248 — Volnewmer™Classys, Inc. Apr 29, 2024
K233699 — SubtleREFORMAT (1.x)Subtle Medical, Inc. Apr 29, 2024
K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service And Savings, Inc. Apr 29, 2024
K240591 — restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc. Apr 29, 2024
DEN230052 — Eversense AP CGM SystemSenseonics, Incorporated Apr 29, 2024
K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. Apr 29, 2024
K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific Apr 29, 2024
K240568 — DuraPro™ Oscillating SystemGlobus Medical, Inc. Apr 29, 2024
K240062 — ARVIS® ShoulderInsight Medical Systems, Inc. Apr 29, 2024
K240526 — POWEReam Xia/SerratoStryker Instruments Apr 29, 2024
K240102 — Blood Pressure Monitor (TMB-2287-B)Guangdong Transtek Medical Electronics Co., Ltd. Apr 29, 2024
K240872 — Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance Apr 26, 2024
K232298 — DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. Apr 26, 2024
K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. Apr 26, 2024
K232038 — BioStar Single Use Transbronchial Aspiration NeedleBroncus Medical, Inc. Apr 26, 2024
K220272 — cobas pulse blood glucose monitoring systemRoche Diagnostics Apr 26, 2024
K221688 — ASTar BC G- Kit and ASTar InstrumentQ-Linea AB Apr 26, 2024
K233673 — uMR JupiterShanghai United Imaging Healthcare Co., Ltd. Apr 26, 2024
K240091 — NB Mini Implant SystemArum Dentistry Co., Ltd. Apr 26, 2024
K240566 — Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation Apr 26, 2024
K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd. Apr 26, 2024
K233703 — Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. Apr 26, 2024
K232261 — TME Temporary Myocardial ElectrodeOsypka AG Apr 26, 2024
K240324 — EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis) Apr 26, 2024
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