510(k) Clearances in 2023 — Page 59

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 59 of 67)
510(k) clearancesDetails
K230038 — MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)Guangzhou Decheng Biotechnology Co., Ltd. Feb 28, 2023
K230248 — VIOLAVascular Graft Solutions, Ltd. Feb 28, 2023
K223116 — 8X-10-6XXX Camera HeadSanta Barbara Imaging Systems Feb 28, 2023
K221711 — AccuICASArteryFlow Technology Co., Ltd. Feb 28, 2023
K222507 — Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Feb 28, 2023
K230245 — LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. Feb 28, 2023
K223253 — Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd. Feb 27, 2023
K211181 — Idylla MSI TestBiocartis NV Feb 27, 2023
K223075 — Ogmend® Implant Enhancement SystemWoven Orthopedic Technologies Feb 27, 2023
K222173 — Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc. Feb 27, 2023
K220035 — Milli Vaginal DilatorMaterna Medical Feb 27, 2023
K223223 — BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. Feb 27, 2023
K213431 — Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd. Feb 26, 2023
K221702 — CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc. Feb 25, 2023
K221614 — TytoCare Lung Sounds AnalyzerTyto Care , Ltd. Feb 24, 2023
K221592 — AVIEW Lung Nodule CADCoreline Soft Co., Ltd. Feb 24, 2023
K222757 — Clarus ViewerClarus Viewer Corporation Feb 24, 2023
K223759 — Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. Feb 24, 2023
K223900 — babyLance Safety Heelstick (BLM, BLN, BLP)Clinical Innovations, LLC Feb 24, 2023
K223884 — ELITONE Urge Urinary Incontinence DeviceElidah, Inc. Feb 24, 2023
K222386 — VisionbodyVb Technologies AG Feb 24, 2023
K230339 — EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. Feb 24, 2023
K223582 — MectaLock TI Triple Loaded Suture AnchorMedacta International S.A. Feb 24, 2023
DEN220063 — Caption Interpretation Automated Ejection Fraction SoftwareCaption Health, Inc. Feb 24, 2023
K221845 — Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC Feb 24, 2023
K223852 — VySpan™ PCT SystemVy Spine, LLC Feb 24, 2023
K223810 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Sb-Kawasumi Laboratories, Inc. Feb 24, 2023
K230205 — Veloxion SystemCorinth Medtech, Inc. Feb 24, 2023
DEN220065 — Pill Sense SystemEnterasense , Ltd. Feb 24, 2023
K213891 — RealNowYiwei Medical Technology Co., Ltd. Feb 24, 2023
K223231 — Ti-Largo Cervical Interbody SystemFlospine Feb 24, 2023
K213805 — MAGNETOM VidaSiemens Medical Solutions USA, Inc. Feb 24, 2023
K211554 — InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd. Feb 24, 2023
K223544 — LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. Feb 23, 2023
K223229 — MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB Feb 23, 2023
K221559 — Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3Stringking Feb 23, 2023
K230227 — T-Line Hernia MeshDeep Blue Medical Advances, Inc. Feb 23, 2023
K230228 — Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex Corporation Feb 23, 2023
K223797 — Neuro20 Pro SystemNeuro20 Technologies Feb 23, 2023
K223161 — OXY-1 SystemAbiomed, Inc. Feb 23, 2023
K221591 — Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light SourceSchoelly Fiberoptic GmbH Feb 23, 2023
K221564 — Brainomix 360 e-ASPECTSBrainomix Limited Feb 23, 2023
K223209 — Elekta UnityElekta Solutions AB Feb 23, 2023
K213863 — Everion+ SystemBiofourmis Singapore Pte., Ltd. Feb 23, 2023
K223262 — Renuvion® APR HandpieceApyx Medical Corporation Feb 23, 2023
K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker Feb 23, 2023
K223216 — Symphony Thrombectomy SystemTruvic Medical, Inc. Feb 23, 2023
K223233 — Monaco RTP SystemElekta Solutions AB Feb 23, 2023
K222579 — Belun Sleep System BLS-100Belun Technology Company Limited Feb 23, 2023
K230212 — OrthoButton ALRiverpoint Medical, LLC Feb 23, 2023
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