510(k) Clearances — Page 166

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 166 of 3,525)
ClearancesDetails
K232022 — CAS-One IRCascination AG Mar 13, 2024
K233466 — Edison SystemHistoSonics, Inc. Mar 13, 2024
K233946 — IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd. Mar 13, 2024
K233930 — MRCP+ version 2 (MRCP+ v2)Perspectum Mar 13, 2024
K233592 — BioPoly Radial Head ImplantBioPoly, LLC Mar 13, 2024
K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter Healthcare Mar 12, 2024
K240416 — Tranquil-C Interbody SystemNexus Spine, LLC Mar 12, 2024
K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc. Mar 12, 2024
K240132 — EmoLED (v. 2-USA)Emoled, Srl Mar 12, 2024
K232564 — Align StudioLaon Medi, Inc. Mar 12, 2024
K240497 — Smartxide Tetra ProEl.En S.P.A. Mar 12, 2024
K233381 — DRX-Evolution Plus SystemCarestream Health, Inc. Mar 12, 2024
K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)Luminex Molecular Diagnostics, Inc. Mar 11, 2024
K231789 — Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)Guangzhou Xinbo Electronic Co., Ltd. Mar 11, 2024
K233922 — SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONGSatelec - Acteon Group Mar 11, 2024
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc. Mar 11, 2024
K233724 — 28mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics Mar 11, 2024
K232140 — OTS HipOrtoma AB Mar 11, 2024
K233912 — ARIX Cannulated Screw SystemJeil Medical Corporation Mar 11, 2024
K234015 — Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited Mar 11, 2024
K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100Codent Technical Industry Co., Ltd. Mar 11, 2024
K233083 — Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) Mar 9, 2024
K231056 — Esperance Distal Access CatheterWallaby Medical Mar 8, 2024
K233359 — DOMINION Expandable Corpectomy SystemAstura Medical Mar 8, 2024
K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardCo-Innovation Biotech Co., Ltd. Mar 8, 2024
K233899 — Knee+Pixee Medical Mar 8, 2024
K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)Steris Mar 8, 2024
K230195 — Neo ADVISE softwareComerge AG Mar 8, 2024
K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Mar 8, 2024
K233758 — Trivicta™ Hip StemOrtho Development Corp. Mar 8, 2024
K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc. Mar 8, 2024
K231813 — Ultrasonic GastrovideoscopeSonoscape Medical Corp. Mar 8, 2024
K233177 — Nest VT Vitrification DeviceCook Incorporated Mar 8, 2024
K233421 — RESCAN 700Carl Zeiss Meditec, AG Mar 8, 2024
K240384 — SENDERO MicrocatheterOkami Medical, Inc. Mar 8, 2024
K233438 — SleepStageMLBeacon Biosignals, Inc. Mar 8, 2024
K231760 — HP-OCT (HP-OCT)Cylite Pty. , Ltd. Mar 8, 2024
K231734 — STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK Mar 8, 2024
K240396 — Elite iQ PRO (M122K1)Cynosure, LLC Mar 8, 2024
K233198 — OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO , Ltd. Mar 8, 2024
K233705 — CellFX Percutaneous Electrode System (SYS3000)Pulse Biosciences, Inc. Mar 8, 2024
K233943 — Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)Medtronic, Inc. Mar 8, 2024
K240264 — Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)Shenzhen Mlay Intelligent Technology Co., , Ltd. Mar 8, 2024
K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation Mar 8, 2024
K232781 — Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd Mar 7, 2024
K240458 — Synthetic Bone PuttyVentris Medical Mar 7, 2024
K232207 — D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd. Mar 7, 2024
K233692 — Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound And Primary Care Diagnostics Mar 7, 2024
K240407 — ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture AnchorStryker Endoscopy Mar 7, 2024
K240371 — 0909FCC, 0909FCC-HSRayence Co., Ltd. Mar 7, 2024
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