510(k) Clearances in 2017 — Page 16

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 16 of 64)
510(k) clearancesDetails
K163696 — SleepImage SystemMycardio, LLC Dba Sleepimage. Oct 13, 2017
K172197 — SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSOrigio A/S Oct 13, 2017
K171286 — PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC Oct 13, 2017
K171916 — Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. Oct 13, 2017
K171702 — Exciplex308nmClarteis Oct 13, 2017
K163653 — NOVOS-NAIL Limb Lengthening System (LLS)Smith & Nephew Oct 13, 2017
K172784 — DX-D Imaging PackageAgfa Healthcare N.V. Oct 13, 2017
K172414 — JUD custom fit condomGlobal Mailer Partners, LLC Oct 12, 2017
K172793 — SKR 3000Konica Minolta, Inc. Oct 12, 2017
K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. Oct 12, 2017
K170085 — SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd. Oct 12, 2017
K171796 — Vial Adapter 15mmMedimop Medical Project , Ltd. Oct 12, 2017
K171169 — Aquarius 8600 1417TG and Aquarius 8600 1717TGImaging Dynamics Company , Ltd. Oct 12, 2017
K170147 — Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation Oct 12, 2017
K171782 — Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugsBlue Sail Medical Co.,Ltd Oct 12, 2017
K171497 — Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd. Oct 12, 2017
K170154 — Creavo Vitalscan MagnetocardiographCreavo Medical Technologies, Ltd. Oct 12, 2017
K170146 — Galaxy UNYCO SystemOrthofix Srl Oct 12, 2017
K171279 — Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free GlovesTop Glove Sdn. Bhd. Oct 12, 2017
K170840 — MAGNETOM TerraSiemens Medical Solutions USA, Inc. Oct 12, 2017
K171874 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)Hartalega Sdn Bhd Oct 12, 2017
K172118 — U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation Oct 11, 2017
K171984 — Clickfine Pen Needle, Penfine Classic Pen NeedleYpsomed AG Oct 11, 2017
K172742 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc. Oct 11, 2017
K162340 — Stomach TubeWell Lead Medical Co., Ltd. Oct 11, 2017
K171765 — Nihon Kohden CO2 MonitorNihon Kohden Corporation Oct 11, 2017
K172123 — NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated Oct 11, 2017
K171593 — InMode RF SystemInmode MD , Ltd. Oct 10, 2017
K172739 — higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)Higi Sh, LLC Oct 10, 2017
K172724 — XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation Oct 10, 2017
K171373 — 3M Bair Hugger Model 675 Total Temperature Management System3M Company Oct 10, 2017
K170079 — Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemTyson Bioresearch, Inc. Oct 6, 2017
K163526 — Bilicocoon™ Phototherapy SystemNeomedlight Oct 6, 2017
K172188 — Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation Oct 6, 2017
K170089 — U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation Oct 6, 2017
K172681 — Edge Air Digital Flat Panel X-ray DetectorOsko, Inc. Oct 6, 2017
K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc. Oct 6, 2017
K170672 — Tamper Evident Cap For use with ENFit SyringesInternational Medical Industries, Inc. Oct 6, 2017
K172672 — Endoscopic Applicator, 41 cmMicromedics, Inc. (D/B/A Nordson Medical) Oct 6, 2017
K171801 — IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP CablePhilips Medizin Systeme Boeblingen GmbH Oct 6, 2017
K170319 — Low Profile Non-Balloon Feeding DeviceApplied Medical Technology, Inc. Oct 6, 2017
K170394 — Kisses MiniAchimhai Medical Corporation Oct 6, 2017
K171397 — Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H. Oct 6, 2017
K172413 — MT ONEM&T S.R.L. Oct 6, 2017
K170281 — MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. Oct 6, 2017
K172406 — Ingenuity TFPhilips Medical Systems (Cleveland), Inc. Oct 6, 2017
K172682 — Edge Digital Flat Panel X-ray DetectorOsko, Inc. Oct 6, 2017
K172399 — MicroMatrixAcell, Inc. Oct 6, 2017
K170470 — Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) Oct 6, 2017
K172408 — Biomet Bone Cement RBiomet, Inc. Oct 5, 2017
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