510(k) Clearances in 2019 — Page 11

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 11 of 59)
510(k) clearancesDetails
K190330 — DRX-Evolution/Plus with Dual EnergyCarestream Health, Inc. Nov 4, 2019
K191634 — Scan Abutments and Comfort CapsDentium Co., Ltd. Nov 4, 2019
K190608 — Mei Ceramic BracketOrthosun Co., Ltd. Nov 4, 2019
K191974 — NuVasive AttraX PuttyNu Vasive, Incorporated Nov 3, 2019
K183465 — Allcem, Allcem CoreDentscare Ltda Nov 2, 2019
K192824 — Parcus Knotless AP Suture AnchorsParcus Medical, LLC Nov 2, 2019
K191622 — Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. Nov 1, 2019
K191497 — NextDent Denture 3D+Vertex-Dental B.V. Nov 1, 2019
K192117 — Small VBR™Ulrich GmbH & Co. KG Nov 1, 2019
K191693 — BC-5Reveallux, Corp Nov 1, 2019
K190189 — MDT2 BLE Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. Nov 1, 2019
K190344 — DePuy Corail AMT Hip ProsthesisDepuy(Ireland) Nov 1, 2019
K191650 — LEGION SystemAlcon Research, LLC Nov 1, 2019
K192278 — Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)Uvision360, Inc. Nov 1, 2019
K183018 — VPro5Propel Orthodontics, LLC Nov 1, 2019
K190190 — WV1 Endoscope270Surgical , Ltd. Nov 1, 2019
K190855 — BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) Nov 1, 2019
K192087 — Combo Electrotherapy DeviceShenzhen Roundwhale Technology Co. , Ltd. Nov 1, 2019
K190544 — XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies Nov 1, 2019
K191016 — COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH Nov 1, 2019
K191597 — Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. Nov 1, 2019
K190898 — Sight OLOSight Diagnostics , Ltd. Nov 1, 2019
K191631 — ZMAXX Dental Zirconia BlanksZmaxx Bioceramics, LLC Nov 1, 2019
K181993 — STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)Sturdy Industrial Co., Ltd. Nov 1, 2019
K192095 — CAPI 3 Immunotyping, Capillarys 3 TeraSebia Nov 1, 2019
K190334 — MIMOSA ImagerMimosa Diagnostics, Inc. Nov 1, 2019
K191312 — Perfect PFETenscare, Ltd. Nov 1, 2019
K190119 — Foryou NPWT Dressing Kit4L Health Co., Ltd. Nov 1, 2019
K192440 — FDR SE LiteFujifilm Corporation Nov 1, 2019
K192345 — MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mLLiofilchem S.R.L. Oct 31, 2019
K190747 — ClaritagDgi Technologies Oct 31, 2019
K183412 — mediCAD WebMedicad Hectec GmbH Oct 31, 2019
K192867 — Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation Oct 31, 2019
K191769 — ePM Series Patient monitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 31, 2019
K190281 — Ultrasonic Surgical SystemMedisonic Technology CO Oct 31, 2019
K190047 — StimRouter Neuromodulation SystemBioness, Inc. Oct 31, 2019
K192961 — ADH193M Deutschland GmbH Oct 31, 2019
K192110 — Vitek DensichekbioMerieux, Inc. Oct 31, 2019
K191002 — OR3O Dual Mobility SystemSmith & Nephew, Inc. Oct 31, 2019
K192743 — VisionX 2.4Durr Dental SE Oct 31, 2019
K192525 — 087 Balloon Guide Catheter SystemQ'Apel Medical, LLC Oct 31, 2019
K191896 — Belimed Steam Sterilizer MST-H TOP 5000Belimed AG Oct 31, 2019
K192790 — Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. Oct 30, 2019
K190267 — EZE SIT ValvulotomeLemaitre Vascular Oct 30, 2019
K192504 — Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. Oct 30, 2019
K190921 — Arthrex Low Profile ScrewsArthrex, Inc. Oct 30, 2019
K192783 — Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support ProfileScientia Vascular, LLC Oct 30, 2019
K191170 — Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterInnovative Health, LLC Oct 30, 2019
K192083 — Okami Medical LOBO Vascular Occlusion SystemOkami Medical Oct 30, 2019
K191264 — Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust Oct 30, 2019
← Previous Page 11 of 59 Next →