510(k) Clearances in 2022 — Page 27

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 27 of 65)
510(k) clearancesDetails
K221126 — Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancetsOwen Mumford, Ltd. Aug 12, 2022
K202739 — Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring SystemBioland Technology, Ltd. Aug 12, 2022
K220385 — Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd. Aug 12, 2022
K222082 — aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devicesCarlsmed, Inc. Aug 12, 2022
K202508 — Hemo-Lyte C CartridgeDi-Chem, Inc. Aug 12, 2022
K220349 — TeraRecon NeuroTerarecon,Inc. Aug 12, 2022
K220434 — Blue Eye (TS-905)The Standard Co., Ltd. Aug 12, 2022
K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))Allmed Medical (Hubei) Protective Products Co., Ltd. Aug 12, 2022
K220835 — ArklignersArklign Laboratories Aug 12, 2022
K222145 — EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. Aug 12, 2022
K221049 — Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC Aug 12, 2022
K220090 — Visibly Digital Acuity ProductVisibly, Inc. Aug 12, 2022
K220680 — Denture Base PolymersShandong Huge Dental Material Corporation Aug 12, 2022
K202461 — ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC Aug 12, 2022
K213686 — SKOUT SoftwareIterative Scopes, Inc. Aug 12, 2022
K220403 — Vibe SF Self-Fitting Hearing AidWsaud A/S Aug 12, 2022
K221131 — Tasso+Tasso, Inc. Aug 12, 2022
K221466 — IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO , Ltd. Aug 12, 2022
K220648 — OMF ASP SystemVha Dean Aug 11, 2022
K221177 — Erbe's Tubing/Cap SetsErbe USA, Inc. Aug 11, 2022
K222414 — TERA HARZ DENTUREGraphy, Inc. Aug 11, 2022
K210949 — Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. Aug 11, 2022
K222161 — Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc. Aug 11, 2022
K220731 — Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker Aug 11, 2022
K213713 — AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH Aug 11, 2022
K220472 — NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. Aug 11, 2022
K220050 — KLS Martin IPS DistractionKLS Martin L.P. Aug 11, 2022
K212361 — NovoPathAI, Inc. Aug 11, 2022
K220910 — Medical image processing softwareHangzhou Deepwise & League Of PHD Technology Co., Ltd. Aug 11, 2022
K220308 — Patient Monitor: RespArrayEdan Instruments, Inc. Aug 11, 2022
K221737 — InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc. Aug 11, 2022
K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)Ovesco Endoscopy AG Aug 11, 2022
K213524 — CytonPro-5000Cytonsys, Inc. Aug 10, 2022
K220900 — Safety Blood Collection Needles with/without Needle HolderAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Aug 10, 2022
K221879 — Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc. Aug 10, 2022
K212763 — UniVit HE, UniVit UHSVisioncare Devices, LLC Aug 10, 2022
K221381 — KDG AbutmentsKeystone Dental, Inc. Aug 10, 2022
K220056 — iSyncWaveiMediSync, Inc. Aug 10, 2022
K212364 — BLT Dental Implant SystemBio Concept Co., Ltd. Aug 10, 2022
K222083 — LimFlow V-CeiverLimFlow, Inc. Aug 9, 2022
K220241 — “POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc. Aug 9, 2022
K221776 — NextGen Pedicle Screw SystemCorelink, LLC Aug 9, 2022
K213609 — NOVA RESIN dual cure, self adhesive resin cementImicryl Dis Malzemeleri Sanayi VE Ticaret AS Aug 9, 2022
K220077 — IMICRYL Composite, Composite Flow MaterialsImicryl Dis Malzemeleri Sanayi VE Ticaret AS Aug 9, 2022
K221789 — IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc. Aug 9, 2022
K222357 — DenMat Glutaraldehyde DesensitizerDenmat Holding, LLC Aug 9, 2022
K212482 — Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural WhiteSri Trang Gloves (Thailand) Public Company Limited Aug 9, 2022
K222072 — Dolphin Imaging 12.0Patterson Dental Supply, Inc. Aug 8, 2022
K212243 — VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc. Aug 8, 2022
K211675 — Dasky Disposable Sampling Tube (Model name: VSM02)Ningbo Dasky Life Science Co., Ltd. Aug 8, 2022
← Previous Page 27 of 65 Next →