510(k) Clearances in 2020 — Page 6

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 6 of 59)
510(k) clearancesDetails
K203253 — NuVasive ACP SystemNu Vasive, Incorporated Dec 3, 2020
K200404 — ORISE ProKnifeBoston Scientific Corporation Dec 3, 2020
K203367 — LineSider™ Spinal SystemIntegrity Implants, Inc. Dec 3, 2020
K201167 — AireHealth NebulizerTMAirehealth, Inc. Dec 3, 2020
K202452 — NobelProcera Zirconia Implant BridgeNobel Biocare AB Dec 3, 2020
K202418 — Magic UCLA Abutment SystemInnobiosurg Co., Ltd. Dec 3, 2020
K201729 — Medical MaskZhende Medical Co., Ltd. Dec 3, 2020
K193008 — Tricoglam Home UseAdvihair S.R.L. Dec 3, 2020
K201940 — Braces on Demand BracketBraces On Demand, Inc. Dec 3, 2020
K202034 — aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. Dec 3, 2020
K200719 — NuVasive Navigation.S InstrumentsNu Vasive, Incorporated Dec 2, 2020
K200572 — Planmeca RomexisPlanmeca Oy Dec 2, 2020
K203041 — SMS Cementless StemMedacta International S.A. Dec 2, 2020
K203053 — Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Dec 2, 2020
K202270 — EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC Dec 2, 2020
K202565 — WAVICIDE-OPA MEC IndicatorSerim Research Corporation Dec 2, 2020
K202384 — Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co. , Ltd. Dec 2, 2020
K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC Dec 2, 2020
K203159 — Lux 35 DetectorCarestream Health Dec 2, 2020
K202835 — Auryon Atherectomy SystemEximo Medical, Ltd. Dec 2, 2020
K201015 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Dec 1, 2020
K202069 — BASE4 Disposable Medical MaskBase4 Group, Inc. Dec 1, 2020
K202377 — Palm Care Latex Examination Powder Free GlovesHi-Care Thai Gloves Co. , Ltd. Dec 1, 2020
K202659 — Stryker ArthroscopeStryker Dec 1, 2020
K192970 — SLIMUSHironic Co., Ltd. Dec 1, 2020
K203199 — RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-DisinfectorSTERIS Corporation Dec 1, 2020
K202388 — Apolo D / Apolo SVmi Tecnologias Ltda Dec 1, 2020
K202876 — Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) Dec 1, 2020
K201712 — Z5-TLZ-Systems AG Dec 1, 2020
K202416 — Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric AcidKimberly Clark Corporation Nov 30, 2020
K201687 — Avenda Health Treatment SystemAvenda Health, Inc. Nov 30, 2020
K200372 — Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencilModern Medical Equipment Manufacturing, Ltd. Nov 30, 2020
K200155 — Bright High FlowGenoss Co., Ltd. Nov 30, 2020
K202851 — Spo2 SensorJkh USA, LLC Nov 27, 2020
K201173 — E-GuardEnvisiontec GmbH Nov 27, 2020
K201653 — Compex Sport Elite 3.0Djo, LLC Nov 27, 2020
K201294 — Pulse OximeterGuangdong Long Yao Electronic Technology Co., Ltd. Nov 27, 2020
K201308 — Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical Nov 27, 2020
K203268 — Arthrex FiberTak Suture AnchorArthrex, Inc. Nov 27, 2020
K202098 — GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC Nov 25, 2020
K192285 — CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou) Nov 25, 2020
K192406 — AveCure BT Microwave Ablation SystemMedwaves, Inc. Nov 25, 2020
K203216 — The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V. Nov 25, 2020
K192177 — SysMed S/TSysmed (China) Co., Ltd. Nov 25, 2020
K202194 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyDepuy Ireland UC Nov 25, 2020
K200761 — Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc. Nov 25, 2020
K201193 — SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside SystemSeaSpine Orthopedics Corporation Nov 25, 2020
K202883 — Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd. Nov 25, 2020
K200484 — CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. Nov 25, 2020
K202465 — Night Guard3D Diagnostix, Inc. Nov 25, 2020
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