510(k) Clearances

174,759 clearances total

K240002 — G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232879 — Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240696 — Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., Ltd. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233991 — CanGaroo RM Antibacterial EnvelopeElutia, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240817 — VersaWrapAlafair Biosciences, Inc. Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241499 — 21.3” 5MP Color LCD Display UMD5-21B01Acula Technology Corp. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232930 — VERVEOculomotor Technologies Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233821 — F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233662 — Radiography 7300 CPhilips Medical Systems Dmc GmbH Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240815 — Arthrex Cannulated Screw SystemArthrex, Inc. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240460 — FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)FMD Co., Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233925 — Relu CreatorRelu BV Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240017 — InMode System with the Morpheus8 90 ApplicatorInMode , Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241370 — Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)ABBOTT MEDICAL Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241358 — BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170ESun Pharmaceutical Industries, Inc. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232953 — AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233892 — 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240149 — Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step MediumGimbo Medical Technology Shenzhen Co., Ltd. Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231060 — ProMin Dental Desensitizing GelBelport Company, Inc., Gingi-Pak Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240876 — Identity Shoulder SystemZimmer, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233266 — MEDIBLU ECG SYSTEMMediblu Medical, LLC Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)Medtronic, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240516 — RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232950 — Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needlePerfect Medical Industry (Vn) Co., Ltd. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240050 — SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233007 — Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240256 — Remunity SystemDeka Research and Development Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233610 — ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240504 — PLASMA EDGE SystemLamidey Noury Medical Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233613 — ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240910 — EO Chex Indicator TapePropper Manufacturing Co., Inc. Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN230069 — Mi-CHORD SystemLsi Solutions, Inc. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K221547 — InActiv BlueFertipro NV Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K230546 — SIGNEXOsteonic Co., Ltd. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241025 — JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232749 — DOOPANGYbrain, Inc. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241011 — Mako Total Knee ApplicationMako Surgical Corp. Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241344 — MetriCide™ OPA Plus Solution Test StripSteris Tue Jun 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240644 — Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233767 — OmniTom EliteNeurologica Corporation Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234106 — Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240111 — VenueGE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240108 — Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)Gymmax Technology Shenzhen Co., Ltd. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241399 — Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240283 — BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)MacroLux Medical Technology Co., Ltd. Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240053 — Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240206 — Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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