510(k) Clearances in 2017 — Page 23

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 23 of 64)
510(k) clearancesDetails
K172033 — Pirouette High Pressure (HP)Arravasc, Ltd. Aug 31, 2017
K171791 — MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated Aug 31, 2017
K172055 — DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc. Aug 31, 2017
K171570 — Additional VIPER PRIME™ screws with fenestrationsMedos International SARL Aug 31, 2017
K172106 — SHOFU MZ Primer PlusShofu Dental Corporation Aug 31, 2017
K171224 — Arctic Sperm Cryopreservation MediumIrvine Scientific Sales Co., Inc. Aug 31, 2017
K163485 — SmartTouchAdherium (Nz), Ltd. Aug 30, 2017
K163628 — Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV Aug 30, 2017
K171540 — Refobacin Bone Cement RBiomet, Inc. Aug 30, 2017
K170564 — MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. Aug 30, 2017
K172049 — CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMEDCry IQ AB Aug 30, 2017
K170467 — Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH Aug 30, 2017
K171626 — truFreeze SystemCSA Medical, Inc. Aug 30, 2017
K171321 — K2M Navigation InstrumentsK2M Aug 30, 2017
K171985 — Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. Aug 30, 2017
K172021 — LigaPASSMedicrea International SA Aug 30, 2017
K172274 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mLThermo Fisher Scientific Aug 30, 2017
K171506 — EasyscreenMaico Diagnostics GmbH Aug 29, 2017
K171329 — Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC Aug 29, 2017
K171896 — Feminine Personal Trainer (FPT)Ralston Group Aug 29, 2017
K162943 — SyMRISyntheticmr AB Aug 29, 2017
K171039 — Assut Filbloc Permanent SuturesAssut Europe S.P.A. Aug 29, 2017
K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. Aug 29, 2017
K170958 — ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc. Aug 29, 2017
K171741 — LaportSejong Medical Co., Ltd. Aug 29, 2017
K171592 — CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation Aug 29, 2017
K163385 — Cortex Dental Implant SystemCortex Dental Implants Industries , Ltd. Aug 29, 2017
K170722 — Moxxly Flow Collection SystemMoxxly, Inc. Aug 28, 2017
K170010 — Salle Intraoperative Pyeloplasty Stent SetCook Incorporated Aug 28, 2017
K162543 — Reverse Pull Adjustable FacemaskSawbros Industries Pvt., Ltd. Aug 28, 2017
K172131 — 2 Hole Lateral Plating SystemLife Spine, Inc. Aug 28, 2017
K171567 — IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. Aug 28, 2017
K171561 — Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White ReloadDextera Surgical, Inc. Aug 28, 2017
K170987 — Captus Vascular Retrieval SystemAvantec Vascular Corporation Aug 28, 2017
K171181 — PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. Aug 28, 2017
K171560 — OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. Aug 25, 2017
K171191 — Hexagen DermGlobal Health Solutions, LLC Aug 25, 2017
K171487 — Sirius MRI Marker NSC4 Imaging, LLC Aug 25, 2017
K163441 — Locking Cage, Full XPE CupUnited Orthopedic Corporation Aug 25, 2017
K172002 — Catalys Precision Laser SystemAmo Manufacturing USA, LLC Aug 25, 2017
K172073 — Hi-Torque Command 18 Guide WireAbbott Vascular Aug 25, 2017
K171104 — Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd Aug 25, 2017
K172207 — Standard Supreme Sterilization WrapperStandard Textile Co., Inc. Aug 25, 2017
K171346 — Sapphire SetsIcu Medical Aug 25, 2017
K161298 — ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd. Aug 25, 2017
K171716 — SKR 3000Konica Minolta, Inc. Aug 25, 2017
K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd. Aug 25, 2017
K170136 — Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Feiyang Professional Gloves Co., Ltd. Aug 25, 2017
K172327 — VMA™ System version 3.0Ortho Kinematics, Inc. Aug 25, 2017
K163647 — Revolve Envi 600 Advanced Adipose SystemLifecell Corporation Aug 25, 2017
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