510(k) Clearances in 2020 — Page 17

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 17 of 59)
510(k) clearancesDetails
K202477 — EndoGI S-Path Biliary Stent SystemEndo GI Medical Sep 24, 2020
K201260 — Dermal Cooling SystemR2 Technologies, Inc. Sep 24, 2020
K201051 — Straumann BoneCeramicInstitut Straumann AG Sep 24, 2020
K200115 — Cavetto-SA Cervical Cage SystemNeurostructures, Inc. Sep 24, 2020
K202572 — GXR-Series Diagnostic X-Ray SystemDRGEM Corporation Sep 24, 2020
K200414 — Pulse OximeterShenzhen Aeon Technology Co., Ltd. Sep 23, 2020
K193276 — Nerve and Muscle StimulatorShenzhen Xft Medical Limited Sep 23, 2020
K202479 — IBS Implant SystemInnobiosurg Co., Ltd. Sep 23, 2020
K200416 — Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated Sep 23, 2020
K202569 — Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC Sep 23, 2020
K201367 — FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. Sep 23, 2020
K201346 — DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mmSynthes (USA) Products, LLC Sep 23, 2020
K201208 — Halo AF Detection SystemLivmor Sep 23, 2020
K200843 — Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy DrugsO&M Halyard, Inc. Sep 22, 2020
K200123 — Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC Sep 22, 2020
K200987 — LTJ Screws and WasherAzurmeds, Inc. Sep 22, 2020
K202210 — Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation Sep 22, 2020
K202448 — DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc. Sep 22, 2020
K201717 — BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. Sep 22, 2020
K201467 — Blood Pressure Monitor-Model 2005, 2006-2, 2006-2BBioland Technology, Ltd. Sep 21, 2020
K201278 — World Hip Stem, World Cup, World LinerSignature Orthopaedics Pty, Ltd. Sep 21, 2020
K192814 — Pounce Thrombus Retrieval SystemSurmodics,Inc. Sep 21, 2020
K201290 — Medline DeNovo 4Pro Electrical Stimulation DeviceMedline Industries, Inc. Sep 21, 2020
K192707 — Optiflux F180NR DialyzerFresenius Medical Care Renal Therapies Group, LLC Sep 21, 2020
K201350 — CORVUSBest Nomos Sep 20, 2020
K200603 — AAA ModelPhilips Ultrasound, Inc. Sep 20, 2020
K201532 — B&J DVT Calf/Thigh Garments, Models 801/830 SeriesB&J Manufacturing , Ltd. Sep 19, 2020
K201746 — Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited Sep 18, 2020
K201547 — B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing , Ltd. Sep 18, 2020
K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLC Sep 18, 2020
K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC Sep 18, 2020
K193368 — Smart Correction SystemWishbone Medical, Inc. Sep 18, 2020
K201013 — Optixon 1-DayOptixon, Inc. Sep 18, 2020
K201073 — Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation Sep 18, 2020
K201390 — Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)Medline Industires, Inc. Sep 18, 2020
DEN200010 — Spineology Interbody Fusion SystemSpineology, Inc. Sep 18, 2020
K201673 — SMS Cementless StemMedacta International S.A. Sep 18, 2020
K201538 — Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. Sep 18, 2020
K200852 — EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound And Primary Care Diagnostics Sep 18, 2020
K190798 — LaborView™ LV1000 Wireless Electrode SystemObmedical Company Sep 18, 2020
K202022 — GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)Medacta International S.A. Sep 18, 2020
K192375 — Intellifuse Administration and Intellifuse Blood Administration SetsSmiths Medical Asd, Inc. Sep 18, 2020
K201224 — Electrosurgical Generator and AccessoriesMedrange Sep 18, 2020
K202399 — OrthoButton FLRiverpoint Medical Sep 18, 2020
K201992 — Caption GuidanceCaption Health Sep 18, 2020
K202463 — Disposable Surgical MaskUnisources Group, LLC Sep 18, 2020
K202287 — Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation Sep 18, 2020
K192890 — SentEPSentiar, Inc. Sep 18, 2020
K201642 — Paragon Adult Maxi PMP Oxygenator with Tubing PackChalice Medical , Ltd. Sep 18, 2020
K200174 — DIA-ROOT BIO MTADiaDent Group International Sep 18, 2020
← Previous Page 17 of 59 Next →