510(k) Clearances

174,759 clearances total

K231185 — MapRTVision Rt, Ltd. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223159 — Radixact Treatment Delivery SystemAccuray Incorporated Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220955 — Hudson RCI Variable concentration Large Volume Nebulizer (1770)Medline Industires, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-Karl Storz Endoscopy America, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230276 — TECHFIT DISRP® SystemTechfit Digital Surgery Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230774 — PERLA® TL System; TEKTONA® HV US Bone CementSpineart Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230322 — SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231202 — QuickRayPRODenterprise International, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223558 — CUVIS-spineCurexo, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230444 — Talee, Talee PostOpInvent Medical USA, LLC Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230497 — Bladder AI (AIBV01)Exo, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222932 — INVOcell Intravaginal Culture SystemInvo Bioscience Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223083 — Straumann SLActive labeling changesInstitut Straumann AG Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231131 — Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223871 — Miria Skin Treatment SystemAVAVA, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223379 — Portable Oxygen Concentrator (Model: P2-E7, P2-E)Qingdao Kingon Medical Science and Technology Co., Ltd. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230904 — Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230599 — TargetCool™Recensmedical, Inc. Thu Jun 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231469 — PAXgene® Blood DNA TubePreanalytix GmbH Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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 Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221311 — Antibacterial BandageWinner Medical Co., Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230886 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlStryker Endoscopy Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231031 — ACL TOP Family 70 SeriesInstrumentation Laboratory Company Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231212 — da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFRayence Co., Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222658 — Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223033 — Tixel® 2 SystemNovoxel , Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231485 — iLet® ACE PumpBeta Bionics, Inc. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230506 — PureLift Pro EditionXtreem Pulse Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231489 — Sturdy Autoclave Super MicromSturdy Industrial Co., Ltd. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223248 — Tablo® Hemodialysis SystemOutset Medical, Inc. Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231533 — Habib EndoHPBBoston Scientific Corporation Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223029 — Perfit CLVatech Mcis Co., Ltd. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230796 — Sparrow AscentSpark Biomedical, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223522 — NC° Thermometer (Gen 3), Model Number: NCTG3Xiamen Intretech, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230993 — CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223535 — SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221024 — tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230346 — Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231148 — ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223103 — BethaLoc® stem cementless HAImplantcast GmbH Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231459 — HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222998 — F3Acrew Imaging, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230781 — Belle SensilubeRb Health (Us), LLC Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220072 — Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd. Sun Jun 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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 Sat Jun 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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 Sat Jun 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
← Previous Page 184 of 3496 Next →