510(k) Clearances in 2020 — Page 55

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 55 of 59)
510(k) clearancesDetails
K191539 — 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH Jan 31, 2020
K193284 — Physica LMC Knee SystemLima Corporate S.P.A. Jan 31, 2020
K193270 — CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. Jan 31, 2020
K192535 — Unshaded Dental Zirconia and Pre-Shaded Dental ZirconiaQinhuangdao Audental Metal Technology Co., Ltd. Jan 31, 2020
K190956 — SCS 17-01Anika Therapeutics, Inc. Jan 30, 2020
K192397 — TruDi Navigation SystemBiosense Webster Jan 30, 2020
K192889 — NeoEemagine Medical Imaging Solutions GmbH Jan 30, 2020
K193339 — GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd. Jan 30, 2020
K190734 — Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC Jan 30, 2020
K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc. Jan 30, 2020
K193057 — ATTUNE All-Polyethylene TibiaDepuy Ireland UC Jan 30, 2020
K191254 — EndoClotEndoclot Plus Co., Ltd. Jan 30, 2020
K193060 — Noritake Super Porcelain EX-3Kuraray Noritake Dental, Inc. Jan 30, 2020
K192941 — HySil Super Fast Impression MaterialsOsstem Implant Co., Ltd. Jan 30, 2020
K193051 — LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetDiaSorin, Inc. Jan 29, 2020
K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook Incorporated Jan 29, 2020
K193642 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. Jan 29, 2020
K193099 — Anatomical Shoulder SystemZimmer GmbH Jan 29, 2020
K183106 — TruAbutment DSTruabutment, Inc. Jan 29, 2020
K191837 — UniSmile Clear Aligner SystemVitang Technology, LLC Jan 29, 2020
K191677 — MectaTap TI Suture AnchorMedacta International S.A. Jan 29, 2020
K191472 — Biopsy NeedleUshare Medical, Inc. Jan 29, 2020
K191380 — Quantum® Total Ankle ProsthesisIn2Bones Sas Jan 29, 2020
K192585 — Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser CapPjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC Jan 29, 2020
K191937 — Ezvena IPC, Ezvena SQSEezcare Medical Corp Jan 29, 2020
K191323 — Carescape B850GE Healthcare Finland Oy Jan 29, 2020
K191989 — WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx Jan 29, 2020
K191926 — VITA VIONIC BondVita Zanhnfabrik H. Rauter GmbH Co. Jan 29, 2020
K192581 — The NightBlocks ApplianceAdvanced Facialdontics, LLC Jan 28, 2020
K192146 — V-DENUPETVitromed GmbH Jan 28, 2020
K193637 — MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic SystemCompania Mexicana DE Radiologia Cgr, S.A. DE C.V. Jan 28, 2020
K193510 — Terason uSmart3200T Ultrasound SystemTeratech Corporation Jan 28, 2020
K193365 — M.U.S.T. Pedicle Screw SystemMedacta International S.A. Jan 27, 2020
K193315 — Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc. Jan 27, 2020
K192090 — CMOS Video Rhino-Laryngoscope SSUKarl Storz SE & CO. KG Jan 27, 2020
K191715 — Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileSTERIS Corporation Jan 27, 2020
K193241 — Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd. Jan 26, 2020
K193512 — THD Procto Software SystemThd Spa Jan 26, 2020
K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural ElectrodeAd-Tech Medical Instrument Corporation Jan 25, 2020
K191249 — CARESCAPE B450GE Healthcare Finland Oy Jan 24, 2020
K193246 — Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation Jan 24, 2020
K192523 — CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG Jan 24, 2020
K191406 — KardiaMobile, KardiaStationAliveCor, Inc. Jan 24, 2020
K193263 — Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC Jan 24, 2020
K192014 — SYPMHONY™ OCT SystemMedos International SARL Jan 24, 2020
K192333 — Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. Jan 24, 2020
K191432 — cortiQ PROG.Tec Medical Engineering GmbH Jan 24, 2020
K193223 — Persona Personalized Knee SystemZimmer, Inc. Jan 24, 2020
K192608 — Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd Jan 24, 2020
K192859 — CareSens S Clear BT Blood Glucose Monitoring SystemI-Sens, Inc. Jan 24, 2020
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