510(k) Clearances in 2017 — Page 10

3,200 510(k) clearances total

Browse FDA 510(k) clearances granted in 2017. RegDataLab tracks 3,200 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2017 (page 10 of 64)
510(k) clearancesDetails
K172759 — Smart External Drain (SED) SystemAqueduct Critical Care, Inc. Nov 14, 2017
K170799 — AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC Nov 14, 2017
K171385 — Planmeca RomexisPlanmeca Oy Nov 14, 2017
K173034 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens Nov 14, 2017
K170859 — Dolphin/IQ and Dolphin/4DViasonix , Ltd. Nov 14, 2017
K172531 — Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc. Nov 14, 2017
K163595 — IMPIX 3D Print CagesMedicrea International SA Nov 13, 2017
K170931 — CXI TriForce Peripheral Crossing SetCook Incorporated Nov 13, 2017
K170524 — Access AMHBeckman Coulter, Inc. Nov 13, 2017
K172344 — Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale Nov 13, 2017
K172525 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd Nov 13, 2017
K170725 — Stryker Universal MeshStryker Nov 13, 2017
K170102 — Pekkton IvoryCendres+Metaux SA Nov 13, 2017
K173166 — ANTHEM Fracture SystemGlobus Medical, Inc. Nov 13, 2017
K172703 — Disposable Snap ElectrodeEmbla Systems Nov 13, 2017
K171868 — A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company Nov 11, 2017
K173271 — Aesculap Slim Clip Applier ForcepsAesculap, Inc. Nov 10, 2017
K171902 — Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc Nov 10, 2017
K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc. Nov 9, 2017
K172124 — Televere Podiatry Digital Imaging SystemTelevere Systems Nov 9, 2017
K172453 — WATCHDOG Hemostasis Valve KitBoston Scientific Corporation Nov 9, 2017
K161923 — J2A SLA Dental Implant SystemKj Meditech Co., Ltd. Nov 9, 2017
K171911 — Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service And Savings, Inc. Nov 9, 2017
K171467 — BioZorb Marker GOLD / LP Marker GOLDFocal Therapeutics Nov 9, 2017
K173273 — Aquarius 8600 1417WCI; Aquarius 8600 1717WCIImaging Dynamics Company , Ltd. Nov 9, 2017
K170664 — Odyssey Micro CatheterHeraeus Medical Components, LLC Nov 9, 2017
K171050 — Geistlich Fibro-GideGeistlich Pharma AG Nov 9, 2017
K170900 — DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + AccessoriesIntervene Group, Ltd. Nov 9, 2017
K170071 — SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/PharyngometerSleep Group Solutions Nov 9, 2017
K162315 — FORTIFY Corpectomy SpacersGlobus Medical, Inc. Nov 9, 2017
K171850 — Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. Nov 9, 2017
K170534 — PROLIXUS TOTAL KNEE SYSTEMOtis Biotech Co., Ltd. Nov 9, 2017
K172700 — OEC OneGe Hualun Medical Systems Co. , Ltd. Nov 9, 2017
K172006 — Alivio Ventricular Catheter and Flusher System (Alivio System)Alcyone Lifesciences, Inc. Nov 9, 2017
K172226 — MX40 Release B.07Philips Medical Systems Nov 9, 2017
K171392 — ulrichINJECT CT motionUlrich GmbH & Co. KG Nov 9, 2017
K170773 — Stryker Universal MeshStryker Nov 8, 2017
K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitCodman & Shurtleff, Inc. Nov 8, 2017
K171131 — MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC Nov 8, 2017
K173247 — Surgical Planning Software version 1.1Ortho Kinematics, Inc. Nov 8, 2017
K170229 — Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. Nov 8, 2017
K172083 — Idys™ ALIF SystemClariance, Sas Nov 8, 2017
K172738 — RadiForce RX560, RX560-AREizo Corporation Nov 8, 2017
K170473 — C2 femoral stemLima Corporate S.P.A. Nov 8, 2017
K172620 — SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC Nov 8, 2017
K171534 — SurgicalPreviewEndo Vantage, LLC Nov 8, 2017
K172790 — ER-REBOA CatheterPrytime Medical Devices, Inc. Nov 8, 2017
K173009 — NCompass Nitinol Stone ExtractorsCook Incorporated Nov 7, 2017
K170595 — IV Administration SetsB.Braun Medical, Inc. Nov 7, 2017
K171004 — Hintermann Series H2 Total Ankle SystemDt Medtech, LLC Nov 7, 2017
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