510(k) Clearances — Page 149

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 149 of 3,525)
ClearancesDetails
K233256 — Robotic Integration InstrumentsDePuy Synthes Jun 17, 2024
K240684 — Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 17, 2024
K233324 — Molecular Transport Media - MTMAlb Luz Jun 17, 2024
K241416 — Ion 3DSurGenTec, LLC Jun 17, 2024
K233987 — VERABAND™Arbor Medical Innovations, LLC Jun 17, 2024
K233255 — CROSSNAV Navigation Enabled InstrumentsDePuy Synthes Jun 17, 2024
K233060 — Elecsys Folate IIIRoche Diagnostics Jun 17, 2024
K241469 — iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation Jun 15, 2024
K231116 — Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd. Jun 15, 2024
K240002 — G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd. Jun 14, 2024
K233991 — CanGaroo RM Antibacterial EnvelopeElutia, Inc. Jun 14, 2024
K233228 — Spine Navigation and Robotic-Assistance DeviceEcential Robotics Jun 14, 2024
K241083 — SIS SystemSurgical Information Sciences, Inc. Jun 14, 2024
K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)Owens & Minor (O&M) Halyard, Inc. Jun 14, 2024
K233238 — Air Pressure Therapy System (Model:VU-IPC4M)Xiamen Weiyou Intelligent Technology Co., Ltd. Jun 14, 2024
K241082 — INNOVERSE Navigation InstrumentsInnosys Co., Ltd. Jun 14, 2024
K233955 — Clarius OB AIClarius Mobile Health Corp. Jun 14, 2024
K240729 — Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)Shenzhen Pango Medical Electronics Co., Ltd. Jun 14, 2024
K240721 — ExcelsiusFlex™Globus Medical, Inc. Jun 14, 2024
K241407 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L. Jun 14, 2024
K233254 — TELIGEN System Navigation Ready InstrumentsDePuy Synthes Jun 14, 2024
K230668 — Disposable High-pressure Extension LinesPrecision Medical Plastics , Ltd. Jun 14, 2024
K233496 — EndeavorOTCAkili Interactive Labs, Inc. Jun 14, 2024
K233707 — HFT150Invent Medical Corporation Jun 14, 2024
K241250 — 3DMax Light MeshDavol Inc., Subsidiary Of C. R. Bard, Inc. Jun 14, 2024
K233043 — Smart Scope® CXPeriwinkle Technologies Pvt., Ltd. Jun 14, 2024
K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,Ltd Jun 14, 2024
K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd. Jun 14, 2024
K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)Cook Ireland, Ltd. Jun 14, 2024
K232879 — Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc. Jun 14, 2024
K240696 — Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd. Jun 14, 2024
K240817 — VersaWrapAlafair Biosciences, Inc. Jun 14, 2024
K240460 — FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)FMD Co., Ltd. Jun 13, 2024
K232953 — AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC Jun 13, 2024
K240815 — Arthrex Cannulated Screw SystemArthrex, Inc. Jun 13, 2024
K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation Jun 13, 2024
K232930 — VERVEOculomotor Technologies Jun 13, 2024
K241499 — 21.3” 5MP Color LCD Display UMD5-21B01Acula Technology Corp. Jun 13, 2024
K233662 — Radiography 7300 CPhilips Medical Systems Dmc GmbH Jun 13, 2024
K233925 — Relu CreatorRelu BV Jun 13, 2024
K233821 — F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. Jun 13, 2024
K240017 — InMode System with the Morpheus8 90 ApplicatorInMode , Ltd. Jun 13, 2024
K241370 — Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)ABBOTT MEDICAL Jun 13, 2024
K241358 — BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170ESun Pharmaceutical Industries, Inc. Jun 13, 2024
K233892 — 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd. Jun 13, 2024
K240149 — Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step MediumGimbo Medical Technology Shenzhen Co., Ltd. Jun 13, 2024
K231060 — ProMin Dental Desensitizing GelBelport Company, Inc., Gingi-Pak Jun 13, 2024
K233266 — MEDIBLU ECG SYSTEMMediblu Medical, LLC Jun 12, 2024
K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. Jun 12, 2024
K240910 — EO Chex Indicator TapePropper Manufacturing Co., Inc. Jun 12, 2024
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