510(k) Clearances

174,759 clearances total

K220728 — vWF AgSiemens Healthcare Diagnostics Products GmbH Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222702 — RGS; RGS MiniGenesis Air, Inc. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222018 — Breathe+Peep Medical, LLC Dba Go2 Devices Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231314 — Fine Osteotomy™Bodycad Laboratories, Inc. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223562 — Xpan Universal Trocar SystemXpan, Inc. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230888 — Titanium TurbineNakanishi, Inc. Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231293 — Drakon™ and Sequre® MicrocathetersAccurate Medical Therapeutics Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223447 — OmniTom EliteNeurologica Corporation, A Subsidiary of Samsung Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230990 — Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223555 — Brainomix 360 e-CTPBrainomix Limited Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)Sb-Kawasumi Laboratories, Inc. Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222905 — Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)Ningbo Maxcon Medical Technology Co., Ltd. Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223299 — Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 AdvanceAmbu A/S Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc. Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223676 — SomniCheckBrainmatterz, LLC Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230617 — Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd. Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230827 — HardyDisk AST Rezafungin 5µg (RZF5)Hardy Diagnostics Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223929 — Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)Innova Vascular, Inc. Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230185 — ANT-X SystemNdr Medical Technology Pte. , Ltd. Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231330 — FiberTak® Suture AnchorArthrex, Inc. Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223498 — Radius VSM and AccessoriesMasimo Corporation Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230542 — Disposable Nitrile Gloves (ABC-DG01)Huizhou Anboson Technology Co., Ltd. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K213010 — FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K211056 — Oxus Sieve BedsOxus, Inc. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K213992 — CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231259 — iRoot SP PlusInnovative Bioceramix, Inc. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230671 — Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222556 — BTL-785XBTL Industries, Inc. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222644 — Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc. Wed May 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222359 — Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (O8t) Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220706 — MyPAO GuidesMedacta International S.A. Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223762 — Smith & Nephew ACCORD™ Cable SystemSmith & Nephew Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230030 — Excipio SV Aspiration Catheter and TubingContego Medical, Inc. Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223523 — Sonic DLGe Medical Systems,Llc (Ge Healthcare) Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230571 — RFP-100A Connector Cable (Single Use)Baylis Medical Technologies, Inc. Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230593 — VictanJiangsu Haize Medical Scientific Development Co., Ltd. Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230278 — Babyroo TN300Draeger Medical Systems, Inc. Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223809 — PrecisionTAVI (v1.1)Dasi Simulations Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230958 — First Glove Blue Nitrile Examination Gloves Powder FreeFirst Glove Sdn. Bhd. Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223841 — KBA3DS.M.A.I.O Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221897 — Hydrozid PreciseBibawo Medical A/S Tue May 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230601 — Blue Nitrile Examination Gloves Powder FreeLatrile Gloves Private Limited Sun May 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222640 — Sweden & Martina Surgical TraysSweden & Martina S.P.A. Fri May 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230044 — Pre-SureLazarus 3D Fri May 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230679 — WellsForm Tricuspid Annuloplasty Band (WF)Genesee Biomedical, Inc. Fri May 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223096 — Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC Fri May 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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