510(k) Clearances in 2017 — Page 33

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 33 of 64)
510(k) clearancesDetails
K170567 — Tempus Pro Patient MonitorRemote Diagnostic Technologies , Ltd. Jul 6, 2017
K170815 — PSA CableBoston Scientific Corporation Jul 6, 2017
K170870 — Site~Rite Halcyon Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd. Jul 6, 2017
K171666 — MPR2 logO DATALOGGERRaumedic AG Jul 6, 2017
K170239 — Leica FL560Leica Microsystems (Schweiz) AG Jul 5, 2017
K171669 — g.Nautilus PROG.Tec Medical Engineering GmbH Jul 5, 2017
K170969 — Eclipse Treatment Planning SystemVarian Medical Systems, Inc. Jul 5, 2017
K170549 — TOKUYAMA CUREGRACETokuyama Dental Corporation Jul 5, 2017
K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpCodman & Shurtleff, Inc. Jul 3, 2017
K171267 — NavLock TrackersMedtronic Navigation Jul 3, 2017
K170434 — Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. Jul 3, 2017
K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service And Savings Inc.(Dba Medline Ren Jul 3, 2017
K170974 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson And Company Jul 3, 2017
K170871 — DigniCap Scalp Cooling SystemDignitana AB Jul 3, 2017
K170844 — Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC Jul 3, 2017
K170706 — Equashield Closed System drug Transfer Device (CSTD)Equashield Medical , Ltd. Jul 3, 2017
K171613 — ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd. Jul 1, 2017
K171612 — ACUITY Pro Lead Delivery SystemBoston Scientific Corporation Jun 30, 2017
K171586 — Smart External Drain (SED) SystemAqueduct Critical Care, Inc. Jun 30, 2017
K163624 — Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)Fujifilm Medical Systems U.S.A, Inc. Jun 30, 2017
K162572 — NextDent Denture, E-DentureVertex-Dental B.V. Jun 30, 2017
K162640 — iVitri EZReprobitech Corp. Jun 30, 2017
K170372 — SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. Jun 30, 2017
DEN160012 — D2 DressingZ-Medica, LLC Jun 30, 2017
K162794 — Gelweave Vascular GraftsVascutek, Ltd. Jun 30, 2017
K170177 — Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation Jun 30, 2017
K171680 — Infinity-Lock 3, Infinity-Lock 5Xiros, Ltd. Jun 30, 2017
K170249 — GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc Jun 30, 2017
K171284 — FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. Jun 30, 2017
K160553 — DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless SSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. Jun 30, 2017
K170794 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)Hartalega NGC Sdn. Bhd. Jun 30, 2017
K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs MonitorWelch Allyn, Inc. Jun 30, 2017
K161710 — SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICALSpinal Analytics & Geometrical Impant Co, LLC Jun 29, 2017
DEN160047 — ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab MBeckman Coulter Jun 29, 2017
K163212 — Parietene DS Composite MeshSofradim Production Jun 29, 2017
K170896 — Admira Fusion x-baseVoco GmbH Jun 29, 2017
K171514 — BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc. Jun 29, 2017
K170940 — Rickettsia Real-time PCR AssayCenters For Disease Control And Prevention (CDC) Jun 29, 2017
K162822 — ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc. Jun 29, 2017
K170684 — Firebow Wire Torque Assist DeviceVesatek, LLC Jun 29, 2017
K163011 — PHA S1 Spinal SystemPhamedica, Inc. Jun 29, 2017
K171533 — Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC Jun 29, 2017
K163397 — SMR Hybrid Glenoid SystemLima Corporate S.P.A. Jun 29, 2017
K163524 — Vessel DilatorFetzer Medical GmbH & Co. KG Jun 29, 2017
K170830 — Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. Jun 28, 2017
K163153 — LiviaLifecare , Ltd. Jun 28, 2017
K170122 — Delta III LithotripterDornier Medtech America Jun 28, 2017
K170213 — SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH Jun 28, 2017
K171239 — TULA Tube Delivery SystemTusker Medical Jun 28, 2017
K170708 — OWL RF INSULATED CANNULAEDiros Technology, Inc. Jun 27, 2017
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