510(k) Clearances

174,759 clearances total

K233788 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233740 — Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232082 — EXPD 4343SDRTECH Corporation Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234123 — Easi-Vue® embolic microspheres SystemAbk Biomedical, Inc. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231990 — Apex LocatorCefla S.C. Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233217 — Mimics Cardiac PlannerMaterialise NV Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233401 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233260 — Univers Revers CA Head and AdapterArthrex, Inc. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233134 — I.T.S. INS Proximal Femur NailI.T.S. GmbH Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232003 — Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233040 — EMS/TENS Massager DeviceShenzhen Imdk Medical Technology Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233533 — NerveTapeBiocircuit Technologies, Inc. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233092 — Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)Chongqing Rob Linka Science and Technology Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233667 — Facial Toning device (UIC-189); Facial Toning device (UIC-589)Body Trim Industrial Co., Ltd. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232674 — PainFreeze IINuance Medical, LLC Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231468 — SCOUT MD Surgical Guidance SystemMerit Medical System, Inc. Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233635 — SPY Cystoscope/HysteroscopeStryker Endoscopy Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231355 — AuroraEnsodata Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240066 — Fine Osteotomy™Bodycad Laboratories, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240098 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232473 — Infrared Thermometer: Model YJ600Zhuhai Yueja Medical Device Technology Co., Ltd. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232072 — AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18GH.S Hospital Service S.P.A Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233638 — VERZA™ High Speed DrillsGlobus Medical, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240072 — Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl CitrateLuliang Hongruida Health Protection Technology Co., Ltd. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231733 — Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies , Ltd. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233631 — ZapStim Controller Application (Z1023)Revital Lab, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234034 — VenaCore Thrombectomy Catheter (46-101)Inari Medical, Inc. Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233464 — WSA Self-Fitting Hearing Aid Gen 2Wsaud A/S Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234037 — CATS-L Tonometer™ PrismCats Tonometer, LLC Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240084 — V-STRUT® Vertebral ImplantHyprevention Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233504 — Lexa MINI (RIS-303, RIS-305)W&H Sterilization S.R.L. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233024 — Alma HarmonyAlma Lasers, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233914 — XVbeam2000Shenzhen Xpectvision Technology Co., Ltd. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231662 — Aid-UIaid Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232854 — Leksell GammaPlan (LGP)Elekta Solutions AB Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231913 — T-FITTechwin Co., Ltd. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233080 — HealthFLDNano-X AI , Ltd. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233476 — Z1 Hip SystemOrchard Medical Development Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K230839 — Concentriq DxProscia, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231536 — eQUANT SystemAvails Medical, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240069 — Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)Endolumik Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233184 — T2Bacteria® PanelT2biosystems, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233350 — SINC Support CatheterReflow Medical, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232644 — neuro42 MRI SystemNeuro42, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231575 — Vecttor VT-300Artaflex, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233480 — Access SHBGBeckman Coulter, Inc. Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240086 — Ion 3DSurGenTec, LLC Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240064 — Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair BoomWontech Co., Ltd. Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240075 — FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232764 — Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateEco Medi Glove Sdn. Bhd. Wed Feb 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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