510(k) Clearances in 2017 — Page 54

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 54 of 64)
510(k) clearancesDetails
K161547 — Transem and EchoGen Embryo Transfer CathetersOrigio A/S Mar 9, 2017
K162506 — PhotoFix Decellularized Bovine PericardiumCryolife, Inc. Mar 9, 2017
K163224 — JAZZ SOLO SensorJazz Imaging, LLC Mar 9, 2017
K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics Mar 9, 2017
K163118 — FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc. Mar 9, 2017
K163286 — ARTIS phenoSiemens Medical Solution USA, Inc. Mar 9, 2017
K163247 — 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC Mar 9, 2017
K160641 — Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular Mar 8, 2017
K163409 — Rampart(TM) T Lumbar Interbody Fusion DeviceSpineology, Inc. Mar 8, 2017
K161898 — Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion SetBeijing Fert Technology Co., Ltd. Mar 8, 2017
K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L. Mar 8, 2017
K162804 — Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. Mar 8, 2017
K162394 — CRC-77tHRCapintec, Inc. Mar 8, 2017
K163489 — OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited Mar 8, 2017
K163054 — DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc. Mar 8, 2017
K163654 — VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocarCovidien, LLC Mar 8, 2017
K161681 — Nipro SafeTouch IV CatheterNipro Medical Corporation Mar 8, 2017
K163307 — Expro Elite Snare, Sympro Elite SnareVascular Solutions, Inc. Mar 8, 2017
K163450 — VIVA combo RF SystemStarmed Co., Ltd. Mar 8, 2017
K170188 — Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratorBovie Medical Corporation Mar 8, 2017
K170095 — Vial2Bag Direct ConnectMedimop Medical Project , Ltd. Mar 8, 2017
K162890 — BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES AbutmentStraumann USA, LLC Mar 8, 2017
K162906 — Flexi-Seal PROTECT Fecal Management SystemConvatec Mar 7, 2017
K160067 — RenovoCathRenovorx, Inc. Mar 7, 2017
K160721 — Vado Steerable SheathKalila Medical, Inc. Mar 7, 2017
K170403 — CenterCross Ultra LV CatheterRoxwood Medical, Inc. Mar 7, 2017
K162919 — Male Latex CondomsZhejiang Xiangban Latex Products Co., Ltd. Mar 7, 2017
K162311 — Straumann PrefGelInstitut Straumann AG Mar 7, 2017
K162870 — CIMLRE F1 and CIMILRE S3Cimilre Co., Ltd. Mar 7, 2017
K161865 — iSage Rx (iSage Rx Basal Insulin Titration)Isag Rx, Inc. Mar 7, 2017
K170346 — PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. Mar 7, 2017
K162033 — SALVATION External Fixation SystemWright Medical Mar 6, 2017
K163436 — Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. Mar 6, 2017
K170430 — TSolution One Surgical System Model 210THINK Surgical, Inc. Mar 6, 2017
K162325 — Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking ScrewExactech, Inc. Mar 6, 2017
K162035 — GMK SphereMedacta International S.A. Mar 6, 2017
K163188 — Next Science Wound Gel (Rx)Next Science, LLC Mar 6, 2017
DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests)Ventana Medical Systems, Inc. Mar 4, 2017
K170350 — ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. Mar 3, 2017
K162646 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)Hartalega NGC Sdn. Bhd. Mar 3, 2017
K162746 — Ontex and other proprietary namesOntex Bvba Mar 3, 2017
K162529 — DigiX FDXAllengers Medical Systems Limited Mar 3, 2017
K163575 — Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. Mar 3, 2017
K162575 — Z-LINKPC SystemZavation, LLC Mar 3, 2017
K161991 — CurasiteIzun Pharmaceuticals Mar 3, 2017
K161918 — SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems Mar 3, 2017
K163552 — iPulse SmoothSkin BARE Hair Removal DeviceCyden Limited Mar 3, 2017
K170058 — TheraView TBICablon Medical B.V. Mar 3, 2017
K170331 — Cyber HoQuanta System Spa Mar 3, 2017
K170164 — 3D OCT-1 MaestroTopcon Corporation Mar 3, 2017
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