510(k) Clearances in 2017 — Page 14

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 14 of 64)
510(k) clearancesDetails
K171489 — Acapella Cervical Spacer SystemChoicespine, LP Oct 23, 2017
K171938 — KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic Oct 23, 2017
K170056 — IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd. Oct 23, 2017
K172213 — MECRON Cannulated Screw SystemMerete GmbH Oct 23, 2017
K172585 — Liberty Anterior Cervical PlateValorus Spine Oct 23, 2017
K172546 — AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd. Oct 23, 2017
K171640 — M-ARS ACL: Anatomic Ribbon Surgery SystemMedacta International S.A. Oct 23, 2017
K171001 — Monosyn Quick Synthetic Absorbable Surgical SutureAesculap, Inc. Oct 23, 2017
K171293 — G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc. Oct 23, 2017
K172254 — Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech Oct 23, 2017
K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. Oct 23, 2017
K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories Oct 23, 2017
K172542 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.Liofilchem S.R.L. Oct 23, 2017
K171277 — Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC Oct 23, 2017
K172805 — gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc. Oct 23, 2017
K171996 — TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC Oct 23, 2017
K171647 — BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company , Ltd. Oct 23, 2017
K171709 — BR-FHUS Viewer 1.0Taihao Medical, Inc. Oct 20, 2017
K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa Oct 20, 2017
K172090 — GuideLiner V3 CatheterVascular Solutions, Inc. Oct 20, 2017
K171052 — Ultimate Contour, Ultimate Contour MiniCAO Group, Inc. Oct 20, 2017
K172027 — Adani MammoScanAdani Oct 20, 2017
K173052 — Heraeus TMW GuidewireHeraeus Medical Components, LLC Oct 20, 2017
K172881 — NeuroBlate SystemMonteris Medical, Oct 20, 2017
K160405 — OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten Oct 20, 2017
K171594 — AccuroRivanna Medical, LLC Oct 20, 2017
K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/S. Meril Endo Surgery Private Limited. Oct 20, 2017
K171987 — Finessis Zero Flexylon Powder Free Sterile White Surgical GloveLucenxia Prescience AG Oct 20, 2017
K172352 — TREFOIL SystemNobel Biocare AB Oct 20, 2017
K170106 — MyKnee PPS-Pin PositionersMedacta International S.A. Oct 20, 2017
K172869 — Discovery XR656 HDGe Hualun Medical Systems Co. , Ltd. Oct 20, 2017
K171257 — ClearPoint SystemMri Interventions, Inc. Oct 20, 2017
K163623 — QuantraHologic, Inc. Oct 20, 2017
K171206 — D'Vill IntroducerNuMED, Inc. Oct 20, 2017
K170371 — DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip SyringeIntervene Group Limited Oct 20, 2017
K170671 — SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC Oct 20, 2017
K163713 — Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation Oct 20, 2017
K162662 — GingiDent Gingival Retraction PastePac-Dent International, Inc. Oct 20, 2017
K172403 — GSI NovusGrason-Stadler, Inc. Oct 20, 2017
K171672 — 065 Zenith, 074 ZenithInneuroco, Inc. Oct 19, 2017
K172811 — EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc. Oct 19, 2017
K170614 — CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemI-Sens, Inc. Oct 19, 2017
K171014 — VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH Oct 19, 2017
K171774 — RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc. Oct 19, 2017
K172281 — PuRE PMMA DiscQuest Dental USA Corp. Oct 19, 2017
K171243 — audifon Tinnitus-ModuleAudiofon USA, Inc. Oct 19, 2017
K162216 — GRI-FILL PERISTALTIC SETLaboratorios Grifols, S.A. Oct 19, 2017
K172376 — Discovery Pico, Discovery Pico PlusQuanta System Spa Oct 19, 2017
K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott Laboratories Oct 19, 2017
K170453 — Medrobotics Flex Robotic SystemMedrobotics Corporation Oct 19, 2017
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