510(k) Clearances in 2020 — Page 11

2,923 510(k) clearances total

Browse FDA 510(k) clearances granted in 2020. RegDataLab tracks 2,923 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2020 (page 11 of 59)
510(k) clearancesDetails
K201683 — PMMA BlockHuge Dental Material Co., Ltd. Nov 3, 2020
K192618 — e-Motion M25Alber GmbH Nov 2, 2020
K202552 — Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss) Nov 2, 2020
K203032 — IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX NeedleGalil Medical, Inc. Nov 2, 2020
K202562 — Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip SetEllusa, LLC Nov 2, 2020
K192904 — SpeediCath Compact SetColoplast Nov 2, 2020
K202558 — Ellusa Bipolar WandsEllusa, LLC Nov 2, 2020
K200316 — UNiD IB3D ALIFMedicrea International SA Oct 30, 2020
K200190 — ScalpelCricVBM Medizintechnik GmbH Oct 30, 2020
K202938 — Aesculap Caiman 5 Seal and Cut Technology SystemAesculap, Inc. Oct 30, 2020
K193296 — eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc. Oct 30, 2020
K201988 — T-LiteSonoscanner Oct 30, 2020
K202497 — Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. Oct 30, 2020
K202901 — Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC Oct 30, 2020
K201695 — Patent Hemostasis Band (PH Band)Medical Ingenuities Oct 30, 2020
K203028 — FUJIFILM Distal End CapFujifilm Corporation Oct 30, 2020
K202556 — HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Oct 30, 2020
K203007 — eKuore Pro SeriesChip Ideas Electronics S.L. Oct 30, 2020
K200323 — AutoContourRadformation, Inc. Oct 30, 2020
K202302 — Atlas Spine Rebar (Ti) Spacer SystemAtlas Spine, Inc. Oct 30, 2020
K202013 — WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. Oct 30, 2020
K193421 — Smart Alarm InterfaceBoxview, LLC Oct 30, 2020
K202157 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management PackSmith & Nephew Medical Limited Oct 30, 2020
K202496 — ANTHEM Fracture SystemGlobus Medical, Inc. Oct 29, 2020
K202142 — Sleepware G3Respironics, Inc. Oct 29, 2020
K193169 — Nelson Sentinel Series Basic Chlorine SentinelNelson Environmental Technologies, Inc. Oct 29, 2020
K193090 — HCG Zirconia Ceramic BlockHocheng Corporation Oct 29, 2020
K202957 — Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc. Oct 29, 2020
K192989 — Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. Oct 29, 2020
K202949 — CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc. Oct 29, 2020
K200425 — Female Luer Lock CapMedsafety Solutions, LLC Oct 29, 2020
K201692 — NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated Oct 29, 2020
K202912 — ARIX Ankle Distal Tibia SystemJeil Medical Corporation Oct 29, 2020
K203058 — CloudVueInternational Medical Solutions, Inc. Oct 29, 2020
K202539 — Nutriglide(TM) Nasal Feeding TubeApplied Medical Technology, Inc. Oct 29, 2020
K202646 — Visera Elite II Video System CenterOlympus Medical Systems Corp. Oct 29, 2020
K200332 — EXPERT - Joint Fixation SystemGM Dos Reis Industria E Comercio Ltda. Oct 29, 2020
K201092 — LSNImaging Biometrics, LLC Oct 29, 2020
K200088 — g.Estim FESG.Tec Medical Engineering GmbH Oct 29, 2020
K202105 — OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC Oct 29, 2020
K192282 — MedCAD® AccuPlan® SystemMedcad Oct 29, 2020
K200299 — Curos Jet Disinfecting Cap3M Company Oct 29, 2020
K193206 — WiZARD 510 Nasal MaskApex Medical Corp. Oct 29, 2020
K200759 — NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. Oct 28, 2020
K200003 — NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. Oct 28, 2020
K201395 — Sterile High-pressure Angiographic Syringes for single-useYouwo (Guangzhou) Medical Device Co., Ltd. Oct 28, 2020
K202935 — Syntec Femoral Nail Extended SystemSyntec Scientific Corporation Oct 28, 2020
K202864 — Tri-Staple 2.0 ReloadsCovidien Oct 28, 2020
K201475 — Ultimate Contour, Ultimate Contour MiniCAO Group, Inc. Oct 28, 2020
K200125 — Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH Oct 28, 2020
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