510(k) Clearances in 2023 — Page 35

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 35 of 67)
510(k) clearancesDetails
K231925 — MINIMA S SystemLima Corporate S.P.A. Jul 11, 2023
K230427 — CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation Jul 11, 2023
K230942 — SPIRA® Posterior Lumbar SpacersCamber Spine Technologies Jul 11, 2023
K231735 — NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody SystemNu Vasive, Incorporated Jul 11, 2023
K230680 — Anthogyr Surgical CassettesAnthogyr Jul 11, 2023
K220646 — Play&Joy InvisiLube Lubricant CapsuleInnovemed Bio-Tech Co., Ltd. Jul 10, 2023
K221307 — Edge Upper Cervical SystemSpinal Simplicity, LLC Jul 10, 2023
K231387 — EndofillLumendo AG Jul 10, 2023
K222666 — X-View 3D Pan/X-View 2D PanTrident S.R.L Jul 10, 2023
K231091 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Jul 10, 2023
K223683 — EnteraLoc FlowVonco Products Jul 10, 2023
K231701 — Ziehm Vision RFD 3DZiehm Imaging GmbH Jul 10, 2023
K223724 — MOZI TPSManteia Technologies Co., Ltd. Jul 10, 2023
K223213 — Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. Jul 10, 2023
K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)Biosense Webster, Inc. Jul 10, 2023
K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc. Jul 10, 2023
K231844 — ProMIS™ Fixation SystemPremia Spine, Ltd. Jul 7, 2023
K230804 — Complement Kit CasesJJGC Indústria E Comércio De Materiais Dentários S.A. Jul 7, 2023
K223578 — T3 Platform softwareEtiometry, Inc. Jul 7, 2023
K230080 — Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, BloodYangzhou Medline Industry, Co., Ltd. Jul 7, 2023
K230932 — ANDORATE® Valve KitGa Health Company Limited Jul 7, 2023
K231253 — Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. Jul 7, 2023
K223382 — AeviceMDAevice Health Pte. , Ltd. Jul 7, 2023
DEN220058 — BT-001Better Therapeutics Jul 7, 2023
K222707 — IH Implant SystemSewonmedix, Inc. Jul 7, 2023
K231668 — Spine CAMP™ (1.1)Medical Metrics, Inc. Jul 7, 2023
K223388 — Invia® Integrated DressingMedela AG Jul 7, 2023
K231318 — Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)Beijing Adss Development Co., Ltd. Jul 7, 2023
K223448 — Bladder Scanner Model: BVT02Xuzhou Kaixin Electronic Instrument Co., Ltd. Jul 7, 2023
K232011 — CleoAmerican Orthodontics Jul 7, 2023
K223806 — VERTICALE® Triangular Fixation SystemSilony Medical GmbH Jul 6, 2023
K221056 — ARGUS PB-3000Schiller AG Jul 6, 2023
K223780 — Lumos 3DX3Dio Jul 6, 2023
K231003 — Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)Guangdong Optomedic Technologies, Inc. Jul 6, 2023
K231339 — Tyber Medical Pin and Wire System (various)Tyber Medical, LLC Jul 6, 2023
K222220 — SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC., Jul 6, 2023
K230968 — VYBE RF Electrosurgical SystemShenB Co., Ltd. Jul 6, 2023
K230173 — Servo-air Lite Ventilator SystemMaquet Critical Care AB Jul 6, 2023
K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)Hardy Diagnostics Jul 6, 2023
K230510 — MyEllevateCynosure, LLC Jul 6, 2023
K223747 — Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) Jul 6, 2023
K220980 — Tissue Approximation System (TAS)Tas Medical, Inc. Jul 5, 2023
K231358 — Universal Seal (5-12 mm)Intuitive Surgical, Inc. Jul 5, 2023
K221058 — LungTrainer (MD2 & MD3)Lung Trainers, LLC Jul 5, 2023
K222015 — Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc. Jul 5, 2023
K231279 — Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc. Jul 5, 2023
K230864 — VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP DaptomycinbioMerieux, Inc. Jul 5, 2023
K230001 — Electric Scooter (Model: M2020)Guangdong Prestige Technology Co., Ltd. Jul 5, 2023
K231641 — Rotium Bioresorbable WickNanofiber Solutions, LLC Jul 5, 2023
K231740 — MemorialTM GlovesUs Glove Supply Jul 4, 2023
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