510(k) Clearances — Page 114

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 114 of 3,525)
ClearancesDetails
K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective CatheterMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jan 2, 2025
K241696 — Ortho AIOrtho Ai, LLC Jan 2, 2025
K241005 — Haemostasis ClipsJiangxi Zhuoruihua Medical Instrument Co., Ltd. Jan 2, 2025
K242989 — Electric Wheelchair (MODEL H)Nanjing E-Take Medical Apparatus Co., Ltd. Dec 31, 2024
K242468 — Power Wheelchair (D10, D12, D15, D17, D20, D37)Anhui Jbh Medical Apparatus Co., Ltd. Dec 31, 2024
K243670 — Idys® LIFClariance Dec 31, 2024
K241852 — Nasal Aspirator (NS 13)Avita Corporation Dec 31, 2024
K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)Genadyne Biotechnologies, Inc. Dec 31, 2024
K241338 — Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd. Dec 31, 2024
K243224 — MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)ABBOTT MEDICAL Dec 31, 2024
K243394 — AF531 Oro-Nasal SE Face MaskRespironics, Inc. Dec 30, 2024
K243445 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L. Dec 30, 2024
K242376 — Next Generation Access PlatformBalt USA, LLC Dec 30, 2024
K242804 — PAL Aspiration SystemMicroaire Surgical Instruments, LLC Dec 30, 2024
K233119 — 8MP Color LCD Displays C811W, C811WT, PA27 and PA27TShenzhen Beacon Display Technology Co., Ltd. Dec 28, 2024
K240828 — OEC One ASDGe Hualun Medical Systems Co. , Ltd. Dec 27, 2024
K243084 — BioTraceIO Precision (2.0)Techsomed Medical Technologies , Ltd. Dec 27, 2024
K243835 — TiLink-P SI Joint Fusion SystemSurGenTec, LLC Dec 27, 2024
K241127 — INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. Dec 27, 2024
K241972 — BLUEDIAMOND IMPLANTMegagen Implant Co., Ltd. Dec 27, 2024
K242252 — Power WheelchairAnhui Jbh Medical Apparatus Co., Ltd. Dec 27, 2024
K241924 — Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd. Dec 27, 2024
K242480 — FLASH EVD System (10-0002)7D Surgical ULC Dec 27, 2024
K233252 — Straumann CARES Visual and Nova Dental CADInstitut Straumann AG Dec 26, 2024
K243141 — Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)Jiangxi Medex Technology Co., Ltd. Dec 26, 2024
K240517 — ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte. , Ltd. Dec 26, 2024
K232966 — FISIOWARM 7.0Golden Star Srl Dec 26, 2024
K243037 — Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd Dec 26, 2024
K243097 — RM STAR EX with RMS NeedleBomtech Electronics Co., Ltd. Dec 26, 2024
K243658 — TMC Compression Implant SystemTreace Medical Concepts Dec 26, 2024
K243677 — iovera° SystemPacira Biosciences, Inc. Dec 26, 2024
K243623 — SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc. Dec 24, 2024
K242434 — Insulin SyringesChirana T. Injecta Dec 24, 2024
K240975 — Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)Beijing Taktvoll Technology Co., Ltd. Dec 23, 2024
K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)Belmont Medical Technologies Dec 23, 2024
K241856 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd. Dec 23, 2024
K242143 — Angiography InjectorShandong Int Medical Instruments Co., Ltd. Dec 23, 2024
K241091 — SIMEOX 200 Airway Clearance DeviceInogen, Inc. Dec 23, 2024
K242573 — NIDO Baby Magnetic Resonance Imaging SystemJiangsu Lici Medical Device Co., Ltd. Dec 23, 2024
K242403 — Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation Dec 23, 2024
K243103 — Denture BaseRiton 3D Technology Co., Ltd. Dec 23, 2024
K242782 — GlassBone GranulesNoraker Dec 23, 2024
K240890 — PanopticAI Vital SignsPanopticAI Technologies Limited Dec 23, 2024
K243693 — NEO Pedicle Screw System™Neo Medical SA Dec 23, 2024
K243177 — SACS PROElastimed , Ltd. Dec 23, 2024
K243248 — INHANCE INTACT™Depuy Ireland UC Dec 23, 2024
K242091 — Bolo Button SystemFusion Orthopedics Dec 23, 2024
K242939 — ARTFX Trauma Bone Plate and Screw SystemArtfx Medical Dec 23, 2024
K233614 — Genadyne DUO NPWTGenadyne Biotechnologies, Inc. Dec 23, 2024
K241288 — Noxturnal WebNox Medical Ehf Dec 23, 2024
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