510(k) Clearances in 2023 — Page 38

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 38 of 67)
510(k) clearancesDetails
K230774 — PERLA® TL System; TEKTONA® HV US Bone CementSpineart Jun 23, 2023
K231202 — QuickRayPRODenterprise International, Inc. Jun 22, 2023
K230444 — Talee, Talee PostOpInvent Medical USA, LLC Jun 22, 2023
K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)Zhuhai Pusen Medical Technology Co., Ltd. Jun 22, 2023
K230904 — Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. Jun 22, 2023
K223558 — CUVIS-spineCurexo, Inc. Jun 22, 2023
K230322 — SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. Jun 22, 2023
K230497 — Bladder AI (AIBV01)Exo, Inc. Jun 22, 2023
K222932 — INVOcell Intravaginal Culture SystemInvo Bioscience Jun 22, 2023
K223083 — Straumann SLActive labeling changesInstitut Straumann AG Jun 22, 2023
K231131 — Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd Jun 22, 2023
K223871 — Miria Skin Treatment SystemAVAVA, Inc. Jun 22, 2023
K223379 — Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science And Technology Co., Ltd. Jun 22, 2023
K230599 — TargetCool™Recensmedical, Inc. Jun 22, 2023
K230886 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlStryker Endoscopy Jun 21, 2023
K223248 — Tablo® Hemodialysis SystemOutset Medical, Inc. Jun 21, 2023
K221311 — Antibacterial BandageWinner Medical Co., Ltd. Jun 21, 2023
K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC Jun 21, 2023
K230309 — Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)Centerline Biomedical, Inc. Jun 21, 2023
K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFRayence Co., Ltd. Jun 21, 2023
K231212 — da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical Jun 21, 2023
K231469 — PAXgene® Blood DNA TubePreanalytix GmbH Jun 21, 2023
K223033 — Tixel® 2 SystemNovoxel , Ltd. Jun 21, 2023
K222658 — Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. Jun 21, 2023
K231031 — ACL TOP Family 70 SeriesInstrumentation Laboratory Company Jun 21, 2023
K231485 — iLet® ACE PumpBeta Bionics, Inc. Jun 21, 2023
K230506 — PureLift Pro EditionXtreem Pulse Jun 21, 2023
K231489 — Sturdy Autoclave Super MicromSturdy Industrial Co., Ltd. Jun 21, 2023
K231533 — Habib EndoHPBBoston Scientific Corporation Jun 21, 2023
K223522 — NC° Thermometer (Gen 3), Model Number: NCTG3Xiamen Intretech, Inc. Jun 20, 2023
K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc. Jun 20, 2023
K230993 — CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech Jun 20, 2023
K223535 — SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC Jun 20, 2023
K223029 — Perfit CLVatech Mcis Co., Ltd. Jun 20, 2023
K222998 — F3Acrew Imaging, Inc. Jun 20, 2023
K230796 — Sparrow AscentSpark Biomedical, Inc. Jun 20, 2023
K221024 — tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. Jun 20, 2023
K230346 — Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC Jun 20, 2023
K231148 — ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd. Jun 20, 2023
K223103 — BethaLoc® stem cementless HAImplantcast GmbH Jun 20, 2023
K231459 — HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. Jun 20, 2023
K230781 — Belle SensilubeRb Health (Us), LLC Jun 20, 2023
K220072 — Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd. Jun 18, 2023
K223917 — VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2PVinno Technology (Suzhou) Co.,Ltd Jun 17, 2023
K223920 — VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35PVinno Technology (Suzhou) Co.,Ltd Jun 17, 2023
K231136 — Fitness Belt (Model: KLT-07)Shenzhen Kelutongda Industrial Co., Ltd. Jun 16, 2023
K223217 — Zynex Monitoring System, Model CM-1600Zynex Medical, Inc. Jun 16, 2023
DEN220048 — NeoasisInvictus Medical, Inc. Jun 16, 2023
K223357 — EyeArt v2.2.0Eyenuk, Inc. Jun 16, 2023
K223556 — DeepCatchMedical IP Co., Ltd. Jun 16, 2023
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