510(k) Clearances in 2022 — Page 19

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 19 of 65)
510(k) clearancesDetails
K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation Sep 28, 2022
K221548 — Dental Air Polishing HandpieceGuilin Woodpecker Medical Instrument Co., Ltd. Sep 28, 2022
K222316 — IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd. Sep 28, 2022
K212143 — Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies , Ltd. Sep 28, 2022
K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condomChurch & Dwight Co., Inc. Sep 28, 2022
K222328 — SteriCUBE® Multiple Tray Sterilization SystemsStericube, LLC Sep 28, 2022
K221397 — MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL Sep 28, 2022
K221211 — Infrared thermometerShenzhen Yolanda Technology Co., Ltd. Sep 27, 2022
K213883 — NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. Sep 27, 2022
K221360 — Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP Sep 27, 2022
K220831 — Dental Implantation Systems, Dental Electrical MotorsFoshan Coxo Medical Instrument Co., Ltd. Sep 27, 2022
K221738 — NS-HGlioNeosoma, Inc. Sep 27, 2022
K220785 — Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd. Sep 27, 2022
K220342 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation Sep 27, 2022
K212561 — MTX-C1Ilooda Co,., Ltd. Sep 27, 2022
K222648 — 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)Philips Ultrasound, LLC Sep 27, 2022
K222661 — Digital Radiography CXDI-CS01Canon, Inc. Sep 27, 2022
K221631 — Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type VOlympus Medical Systems Corp. Sep 26, 2022
K222266 — Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)Jingzhou Haixin Green Cross Medical Products Co., Ltd. Sep 26, 2022
K221062 — RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation Sep 26, 2022
K222655 — OtoSight Middle Ear ScopePhotonicare, Inc. Sep 26, 2022
K221473 — FlowartAsset Medikal Tasarim As. Sep 26, 2022
K220795 — QT ECGQT Medical, Inc. Sep 26, 2022
K214015 — Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC Sep 26, 2022
K222602 — Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)Zhuhai Pusen Medical Technology Co., Ltd. Sep 26, 2022
K220116 — Auryon Atherectomy CathetersEximo Medical, Ltd. Sep 26, 2022
K222629 — Resonic Rapid Acoustic Pulse DeviceZeltiq Aesthetics, Inc. Sep 25, 2022
K212751 — Powder Free Nitrile Examination GloveDainam Glove Joint Stock Company Sep 24, 2022
K222693 — Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong Sep 24, 2022
K221887 — Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White ColorGuangdong Kingfa Sci. & Tech.Co., Ltd. Sep 24, 2022
K222294 — Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric AcidOnetexx Sdn Bhd Sep 24, 2022
K222342 — Betel Gloves Nitrile Examination Glove Powder FreeBetel Care Sdn. Bhd. Sep 24, 2022
K221718 — Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Hartalega NGC Sdn. Bhd. Sep 24, 2022
K220483 — Platform® Acetabular SystemTotal Joint Orthopedics, Inc. Sep 23, 2022
K222204 — Medical Surgical MaskGuangzhou Zhengkang Medical Equipment Co.,Ltd Sep 23, 2022
K222152 — 3M™ Attest™ Hydrogen Peroxide Indicator Tape 12283M Company Sep 23, 2022
K222877 — FREEPRINT crownDetax GmbH Sep 23, 2022
K222265 — DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd Sep 23, 2022
K221724 — Conductive GelTone-A-Matic International, Inc. Sep 23, 2022
K221821 — ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. Sep 23, 2022
K222568 — OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation Sep 23, 2022
K222555 — reepot Nd; YAG laser systemIlooda Co,., Ltd. Sep 23, 2022
K221481 — NeutrArtAsset Medikal Tasarim As. Sep 23, 2022
K222561 — AlignAcuity Surgical Devices, LLC Sep 23, 2022
K220369 — Esthetic ColorantKuraray Noritake Dental, Inc. Sep 23, 2022
K202144 — A.B. Dental Devices Dental Implants SystemA.B. Dental Device , Ltd. Sep 23, 2022
K213339 — DENU Composite Resin, DENU Flow ResinHdi, Inc. Sep 23, 2022
K213759 — XACT Robotic System, ACE ModelXact Robotics, Ltd. Sep 23, 2022
K221829 — Wet Flavored Personal LubricantsTrigg Laboratories, Inc. Sep 23, 2022
K220941 — HotDog Temperature Management SystemAugustine Temperature Management Sep 23, 2022
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