510(k) Clearances in 2019 — Page 45

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 45 of 59)
510(k) clearancesDetails
K181931 — GMC Upper Arm Automatic Blood Pressure MonitorGmc, Inc. Apr 4, 2019
K183445 — Erbe APCapplicatorsErbe Elektromedizin GmbH Apr 4, 2019
K180843 — HIgH-Flo Super26 Subcutaneous Needle SetsRepro-Med Systems, Inc. Dba Rms Medical Products Apr 4, 2019
K182399 — Park Blade Septostomy CatheterCook Incorporated Apr 4, 2019
K183304 — Prettau, ICE, Z-White zirconia blanksZirkonzahn Srl Apr 4, 2019
K182253 — FUJIFILM Video BronchoscopesFujifilm Corporation Apr 4, 2019
K183197 — PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc. Apr 4, 2019
K182943 — VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC Apr 4, 2019
K190289 — Karma® Fixation SystemSpinal Elements, Inc. Apr 3, 2019
K183184 — FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. Apr 3, 2019
K190230 — iFuse Implant System®SI-BONE, Inc. Apr 3, 2019
K182597 — Infrared thermometerShenzhen Pango Electronic Co., Ltd. Apr 3, 2019
K190586 — Monster® Screw SystemParagon 28, Inc. Apr 3, 2019
K180232 — DAEHAN Disposable CUP ElectrodesDaehan Medical Systems Co., Ltd. Apr 3, 2019
K183376 — HORIZON TMS Therapy System with NavigationMagstim Company, Ltd. Apr 3, 2019
K182872 — LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG Apr 3, 2019
K182349 — CONCORDE LIFTMedos International SARL Apr 3, 2019
K190520 — VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. Apr 3, 2019
K190557 — Bio-Medicus Insertion KitMedtronic, Inc. Apr 3, 2019
K183320 — Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical) Apr 2, 2019
K181171 — Zimmer Biomet Ceramic HeadsZimmer, Inc. Apr 2, 2019
K190248 — ARIETTA 50Hitachi Healthcare Americas Apr 2, 2019
K190131 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Apr 2, 2019
K182836 — FUJIFILM Endoscope Model EG-740NFujifilm Corporation Apr 2, 2019
K182221 — Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. Apr 1, 2019
K190447 — 7400 Ultrasound SystemsNavigant Consulting - On Behalf Of Esaote S.P.A. Apr 1, 2019
K183343 — Vantage Total Ankle Flat Cut Talar ComponentsExactech, Inc. Apr 1, 2019
K190629 — DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE Apr 1, 2019
K181597 — Le'PenKmihh, Ltd. Apr 1, 2019
K190180 — CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation Apr 1, 2019
K190198 — Microperimeter MP-3, Microperimeter MP-3 Type SNidek Co., Ltd. Apr 1, 2019
K190648 — Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd. Mar 29, 2019
K182609 — Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE Mar 29, 2019
K182720 — Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated Mar 29, 2019
K182164 — Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandEcolab, Inc. Mar 29, 2019
K180924 — Reflect Implant SystemIds - Integrated Dental Systems Mar 29, 2019
K190178 — Monaco RTP SystemElekta, Inc. Mar 29, 2019
K181352 — Loop SystemSpry Health, Inc. Mar 29, 2019
K182123 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc. Mar 29, 2019
K181777 — AggreGuide A-100 ADPAggredyne, Inc. Mar 29, 2019
K182965 — BL-Cart IOL Delivery CartridgeAst Products, Inc. Mar 29, 2019
K183210 — Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS Mar 29, 2019
K180903 — 3880 MRI Patient Monitoring SystemIradimed Corporation Mar 29, 2019
K183508 — Micro Transgastric-Jejunal Feeding DeviceApplied Medical Technology, Inc. Mar 29, 2019
K190023 — BTL-084BTL Industries, Inc. Mar 29, 2019
K182834 — CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC Mar 29, 2019
K182981 — Confirm Rx Insertable Cardiac MonitorAbbott Mar 29, 2019
K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography CatheterCook Incorporated Mar 29, 2019
K183596 — Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link PolyTotal Joint Orthopedics, Inc. Mar 29, 2019
K183579 — Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific Neuromodulation Mar 29, 2019
← Previous Page 45 of 59 Next →