510(k) Clearances in 2022 — Page 55

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 55 of 65)
510(k) clearancesDetails
K210330 — Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl ResistantWrp Asia Pacific Sdn. Bhd. Mar 4, 2022
K211900 — Patient Information Center iXPhilips Medizin Systeme Böblingen GmbH Mar 4, 2022
K212723 — BTL-995-rTMSBTL Industries, Inc. Mar 4, 2022
K213703 — Surgical GownWujiang Tutaike Textiles & Finishing Co., Ltd. Mar 4, 2022
K211808 — Medcare Powder-Free Blue Nitrile Patient Examination GlovesDongguan Grinvald Technology Co., Ltd. Mar 4, 2022
K212281 — Surgical TraysDentsply Sirona, Inc. Mar 4, 2022
K220051 — TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 4, 2022
K213358 — Surgical MaskShenzhen Safesecure Medical Infection Control Tech Co. , Ltd. Mar 4, 2022
K212940 — Skanmobile, Skanmobile-DrSkanray Technologies Limited Mar 4, 2022
K210216 — Disposable Automatically Retractable Insulin Safety SyringeShantou Wealy Medical Instrument Co.,Ltd Mar 4, 2022
K220327 — geko W-3Firstkind Limited Mar 4, 2022
K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLC Mar 4, 2022
K211843 — PolyLock Plating SystemFusion Orthopedics Mar 4, 2022
K202675 — InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp Mar 4, 2022
K210365 — Second OpinionPearl, Inc. Mar 4, 2022
K213994 — Flexible BlockShandong Huge Dental Material Corporation Mar 4, 2022
K213671 — Astroglide Sensual Strawberry Personal LubricantBiofilm, Inc. Mar 3, 2022
K211787 — HemoclipHangzhou AGS MedTech Co., Ltd. Mar 3, 2022
K220018 — MR Elastography; MZEK-001ACanon Medical Systems Corporation Mar 3, 2022
K212676 — Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) Mar 3, 2022
K212149 — MyndMove 2.0Myndtec, Inc. Mar 3, 2022
K211658 — OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3TNoras Mri Products GmbH Mar 3, 2022
K213285 — easy ClaireY & J Bio Co., Ltd. Mar 3, 2022
K211811 — Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular StaplersWuxi Beien Surgery Device Co., Ltd. Mar 3, 2022
K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V. Mar 3, 2022
K211850 — Air Compression Leg Massager (model: FE-7204B)Xiamen Healthpal Electronic Co.,Ltd Mar 3, 2022
K212720 — nordicDSCNordicneurolab AS Mar 3, 2022
K220379 — IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc. Mar 3, 2022
K213835 — TENS & EMS DeviceShenzhen Jian Feng Electronic Technology Co., Ltd. Mar 3, 2022
K213778 — IV Administration SetB.Braun Medical, Inc. Mar 3, 2022
K210923 — Southern Implants Instrument TraysSouthern Implants (Pty), Ltd. Mar 2, 2022
K212652 — Sterile Syringe with Fixed Safety Needle for Single UseGemtier Medical (Shanghai), Inc. Mar 2, 2022
K220006 — angioLOCK Polymer Ligating ClipA2 Medical Systems, LLC Mar 2, 2022
K211183 — Sugita AVM MicroclipsMizuho America, Inc. Mar 2, 2022
K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation Mar 2, 2022
K212379 — N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH Mar 2, 2022
K213551 — Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. Mar 2, 2022
K214091 — Dental Image Plate Scanner, Model DFC-4T-SMARTHefei Dentafilm Medical Equipment Co., Ltd. Mar 2, 2022
K213567 — Medline UNITE Calcaneal Fracture Plating SystemMedline Industries, LP Mar 2, 2022
K213279 — NovaGuide 2 Intelligent UltrasoundNovasignal Corporation Mar 2, 2022
K201861 — Bio Fluff SystemGnali Bocia S.R.L. Mar 2, 2022
K213553 — Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. Mar 2, 2022
K213579 — Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L Mar 2, 2022
K213127 — ReNew Disposable Scissor TipsMicroline Surgical, Inc. Mar 2, 2022
K203376 — ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400GMedtecs (Taiwan) Corp. Mar 2, 2022
K213457 — Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135Fort Defiance Industries, LLC Mar 2, 2022
K212698 — Plus Medical Isolation Gown Level 3Foshan Nanhai Plus Medical Co, Ltd. Mar 2, 2022
K213932 — A-dec 300, A-dec 500A-Dec, Inc. Mar 2, 2022
K210074 — Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableFresenius Kabi AG Mar 1, 2022
K212365 — BoneViewGleamer Mar 1, 2022
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