510(k) Clearances in 2019 — Page 30

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 30 of 59)
510(k) clearancesDetails
K190011 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jul 10, 2019
K190137 — IdentifyVarian Medical Systems, Inc. Jul 10, 2019
K191408 — Nexxt Matrixx SystemNexxt Spine, LLC Jul 10, 2019
K191045 — Salvo™ Spine SystemSpine Wave, Inc. Jul 10, 2019
K191589 — Calprest, EasyCalEurospital S.P.A. Jul 10, 2019
K190107 — VeriSplintWhip Mix Corporation Jul 10, 2019
K191592 — CalprestNG, EasyCalEurospital S.P.A. Jul 10, 2019
K183041 — Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-Medical Electronics Co., Ltd. Jul 10, 2019
K183243 — Velofix TLIF CageU&I Corporation Jul 10, 2019
K182471 — ScooterTianjin Kepler Vehicle Industry Co. , Ltd. Jul 10, 2019
K191541 — Vave Personal Ultrasound SystemVave Health, Inc. Jul 10, 2019
K190620 — SpeediCath Flex Coude ProColoplast Jul 10, 2019
K190801 — PressOn Electrode HeadsetRhythmlink International, LLC Jul 10, 2019
K182875 — DeepCTDeep01 Limited Jul 10, 2019
K183322 — physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc. Jul 10, 2019
K190818 — Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH Jul 10, 2019
K191557 — CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part Of Abbott) Jul 10, 2019
K183079 — Conometric AbutmentsDentsply Sirona, Inc. Jul 10, 2019
K190528 — MariGen Wound ExtraKerecis Limited Jul 10, 2019
K182829 — Scepter Mini Occlusion Balloon CatheterMicroVention, Inc. Jul 10, 2019
K190969 — ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. Jul 9, 2019
K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc. Jul 9, 2019
K191162 — EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC Jul 9, 2019
K181957 — Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll GussetedTianchang Jiarui Packaging Material Co., Ltd. Jul 9, 2019
K182163 — Shear Stress Therapeutics SST 3000Shear Stress Therapeutics, LLC Jul 9, 2019
K183623 — LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. Jul 9, 2019
K191252 — Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. Jul 9, 2019
K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc. Jul 8, 2019
K191580 — BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc. Jul 8, 2019
K190286 — Materialise Glenoid Positioning SystemMaterialise NV Jul 8, 2019
K183050 — GLISSANT Intimate LubricantVjuvenate, LLC Jul 8, 2019
K181456 — Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclavesTuttnauer , Ltd. Jul 8, 2019
K191384 — RayCare 2.3RaySearch Laboratories AB (PUBL) Jul 8, 2019
K182615 — Surgikor Dental Implant SystemSurgikor, LLC Jul 8, 2019
K190277 — ProVate Vaginal SupportContipi Medical , Ltd. Jul 8, 2019
K180365 — PRAMA White Implant SystemsSweden & Martina S.P.A. Jul 8, 2019
K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc. Jul 8, 2019
K190064 — nView system 1Nview Medical, Inc. Jul 8, 2019
K183153 — Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. Jul 8, 2019
K191238 — Zimmer Guide Wire DevicesZimmer, Inc. Jul 5, 2019
K190456 — BTL 799-2LBTL Industries, Inc. Jul 5, 2019
K190645 — Arthrex NanoScope SystemArthrex, Inc. Jul 5, 2019
K190324 — OrthoPediatrics Cannulated Screw SystemOrthoPediatrics Corp. Jul 5, 2019
K190548 — BIOMONITOR III, Remote Assistant IIIBiotronik, Inc. Jul 5, 2019
K190254 — Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation Jul 5, 2019
K190924 — Revitive Medic Plus, Revitive Advanced 2Actegy , Ltd. Jul 5, 2019
K182414 — Aesculap® SterilContainer(TM) S2 SystemAesculap, Inc. Jul 5, 2019
K191367 — Harrier-SA Lumbar Interbody SystemChoice Spine, LLC Jul 5, 2019
K182901 — Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical Systems Corporation Jul 5, 2019
K190594 — AngioVac C20, AngioVac C180AngioDynamics, Inc. Jul 5, 2019
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