510(k) Clearances

174,759 clearances total

K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)Surgical Instrument Service and Savings, Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241638 — 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc. Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240233 — Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt. , Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242042 — TriALTIS™ Spine SystemMedos International SARL Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)Rayence Co., Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242349 — FoLixLumenis Be, Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241678 — TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240697 — See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241681 — Overjet Image Enhancement AssistOverjet, Inc. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240791 — ADAS 3DAdas3D Medical S.L. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241205 — Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)Shenzhen Ulike Smart Electronics Co., Ltd. Mon Sep 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240486 — PM2 System and ECGuide ConnectorPiccolo Medical, Inc. Sun Sep 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240411 — uAI PortalShanghai United Imaging Intelligence Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232996 — Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO , Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241672 — COPRO 3Amt Engineering Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231667 — Withings Sleep RxWithings Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234044 — ACS® LD FB Knee SystemImplantcast GmbH Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241164 — IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242415 — TMC Compression Implant SystemTreace Medical Concepts Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233911 — VISULAS combiCarl Zeiss Meditec, AG Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233974 — Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241415 — Orchid Safety Release Valve™Linear Health Sciences, LLC Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232543 — MSC SFMYocon Biology Technology Company Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240600 — SafeCross Vascular Introducer System (4001)East End Medical I, LLC Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241976 — nextaro® va, 15mm, 5µmSfm Medical Devices GmbH Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234035 — COSINE™ SpacerGlobus Medical, Inc. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241552 — MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241693 — FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241579 — DD Hybridlayer (multicolored zirconia)Dental Direkt GmbH Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233900 — Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241427 — Access SyphilisBeckman Coulter, Inc. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233921 — Luvis Chair (LC700C)Dentis Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233806 — T2 PlusOsstem Implant Co., Ltd. Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241605 — Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyNanovis, LLC Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242390 — Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231566 — ICX-Implant SystemMedentis Medical GmbH Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241723 — Electric wheelchair (W3902)Zhejiang Richall Medical Technology Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030Prestige Ameritech Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241356 — Fine Osteotomy™Bodycad Laboratories, Inc. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241155 — Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233998 — TRAQinform IQAiq Global, Inc. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232692 — Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)Intradin (Shanghai) Machinery Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241721 — Electric wheelchair (N3901)Zhejiang Richall Medical Technology Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240203 — URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)Dyne Medical Group, Inc. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240158 — Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233977 — VelacurSonic Incytes Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231095 — Tamper Evident CapInternational Medical Industries, Inc. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242305 — BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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