Atlas FDA

2020

2,923 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Venus Viva MD Device (K201164)Venus Concept USA, Inc.2020-06-26
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor (K200250)Megadyne Medical Products, Inc.2020-06-26
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US (K193473)Boston Scientific Corporation2020-06-26
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) (K200723)Medtronic Navigation, Inc.2020-06-26
Stardust Med (K200736)I.T.S. Group S.R.L.2020-06-26
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (K193525)HORIBA ABX SAS2020-06-26
DRX-Compass (K201373)Carestream Health, Inc.2020-06-26
Rapid ASPECTS (K200760)Ischemaview, Inc.2020-06-26
RetroFix (K200226)Retrofix Screws, LLC2020-06-26
Optimized Positioning System (OPS) ReView (K193042)Corin USA2020-06-26
ChartCheck (K201119)Radformation, Inc.2020-06-26
MSDI Dental Implants System (K191443)Medical Systems and Devices International , Ltd.2020-06-26
EndoGI Biliary Stent System (K193600)Endogi Medical, Ltd.2020-06-26
D-Stat Radial Topical Hemostat (K200720)Vascular Solutions, LLC2020-06-26
DuoHex CH Cannulated Hammertoe System (K200840)Nextremity Solutions, Inc.2020-06-26
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License (K201148)ABBOTT MEDICAL2020-06-26
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense (K200825)Hycor Biomedical2020-06-26
Blood Pressure Monitor (K193348)Shenzhen Viatom Technology Co., Ltd.2020-06-25
Blood Pressure Monitor (K200437)Shenzhen Jamr Technology Co., Ltd.2020-06-25
Rotium Bioresorbable Wick (K201414)Nanofiber Solutions, LLC2020-06-25
IlluminOss Bone Stabilization System (K200295)Illuminoss Medical, Inc.2020-06-25
VitriGuard (K200815)Origio A/S2020-06-25
Yumizen C1200 CRP (K192028)HORIBA ABX SAS2020-06-25
DIA-ROOT BIO Sealer (K200175)DiaDent Group International2020-06-25
FiteBac Antimicrobial Cavity Cleanser (K200614)Largent Health, LLC2020-06-25
Bendit2.7 Steerable Microcatheter (K200582)Bend IT Technologies, Ltd.2020-06-25
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (K192221)Implant Direct Sybron Manufacturing, LLC2020-06-25
Lever Action Plate System (K200834)Mcginley Orthpaedic Innovations, LLC2020-06-25
The Simple Locking Intramedullary (Slim) System (K192710)Pega Medical, Inc.2020-06-24
ACUSON Sequoia Diagnostic Ultrasound System (K201462)Siemens Medical Solutions USA, Inc.2020-06-24
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (K200975)Huntleigh Healthcare Limited2020-06-24
The C100 Contactless Breathing Monitor (K200445)Circadia Technologies, Ltd.2020-06-24
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve (K200495)Ga Health Company Limited2020-06-24
CINA (K200855)Avicenna.Ai2020-06-24
Nd: YAG Laser Therapy Systems (K193477)Beijing Kes Biology Technology Co., Ltd.2020-06-24
ControlRad Trace Model 9 (K200663)Controlrad, Inc.2020-06-24
ULab Systems uDesign Software (K200772)Ulab Systems, Inc.2020-06-23
CUSA Clarity Ultrasonic Surgical Aspirator System (K200774)Integra LifeSciences Corporation2020-06-23
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 (K200617)Richard Wolf Medical Instruments Corporation2020-06-23
VarseoSmile Crown plus (K201668)Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG2020-06-23
LVivo Software Application (K200232)Dia Imaging Analysis, Ltd.2020-06-23
CO2mbiLED (K201096)Karl Storz Endoscopy America, Inc.2020-06-23
Byteflies Kit (K192549)Byteflies NV2020-06-22
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (K200195)Northeast Scientific, Inc.2020-06-22
GlidePath 10F Long-Term Dialysis Catheter (K200627)C.R. Bard, Inc.2020-06-22
Air Compression Therapy System (K192466)Shenzhen Lifotronic Technology Co., Ltd.2020-06-22
Axeos (K201140)Dentsply Sirona2020-06-22
Zeroveno (K192337)Dimedi Co., Ltd.2020-06-22
Patient Monitoring Cable (SpO2 Extension Cable) (K192404)Shenzhen Coreray Technology, Ltd.2020-06-22
O-Mec 690 Series Laparoscopes (K201151)Omec Medical, Inc.2020-06-22
Opera Lebody (Gold), Opera Lebody (Zafiro) (K201107)Gtg Wellness Co., Ltd.2020-06-22
InFrame™ Cannulated Fixation System (K201430)Exsomed Corp.2020-06-20
EverLift Submucosal Lifting Agent (K191923)Gi Supply2020-06-20
Multiflex Tinnitus Technology (K201370)Starkey Laboratories, Inc.2020-06-19
The NOxBOXi Nitric Oxide Delivery System (K201339)Praxair, Inc.2020-06-19
Kogent Torus Ultrasonic Aspirator (K192963)Katalyst Surgical, LLC2020-06-19
TruAbutment DS (K191913)Truabutment, Inc.2020-06-19
AQUILA 320 D / AQUILA 320 S (K201340)Vmi Tecnologias Ltda2020-06-19
Cemented TSI Hip Stem (K192024)Signature Orthopaedics Pty, Ltd.2020-06-19
BriefCase (K193298)Aidoc Medical , Ltd.2020-06-19
STATClave G4 Chamber Autoclave (K192910)Scican , Ltd.2020-06-19
Infrared Thermometer Model Number RN-60A,RN-60B (K200471)Ningbo Ranor Medical Science & Technology Co., Ltd.2020-06-19
EksoNR (K200574)Ekso Bionics, Inc.2020-06-19
MPS 3 Myocardial Protection System (K200438)Quest Medical, Inc.2020-06-19
SpineFrontier Lumbar Interbody Fusion Device System (K193106)Spinefrontier, Inc.2020-06-19
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl (K192954)Comfort Rubber Gloves Industries Sdn. Bhd.2020-06-19
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for (K200671)Ansell Healthcare Products, LLC2020-06-19
Fit & Brilliant Dental Implant System (K190637)F&B Technology Co., Ltd.2020-06-19
NUVO IF Implant System (K193234)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2020-06-18
Andorate Biopsy Valve, Andorate Biopsy Irrigator (K200481)Ga Health Company Limited2020-06-18
Giotto Class (Models - 3000X-YY and 4000X-YY) (K200424)Ims Giotto S.P.A.2020-06-18
DePuy ATTUNE™ Total Knee System (K201347)DePuy Orthopaedics, Inc.2020-06-18
Harvey(R) Surgical Assistant (K200892)Orthalign, Inc.2020-06-18
BV Dental Implant System (K192274)Bio Concept Co., Ltd.2020-06-18
TENS and Muscle Stimulator (K200727)Shenzhen Astec Technology Co., Ltd.2020-06-18
PF4 IgG assay (K201311)Immucor Gti Diagnostics, Inc.2020-06-18
Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K200297)Microlife Intellectual Property GmbH2020-06-18
Servo-air 4.0 Ventilator System (K192604)Maquet Critica Care AB2020-06-18
OptoMonitor 3 (K193620)Opsens, Inc.2020-06-18
SIGNAFUSE Bioactive Bone Graft (K193513)Bioventus2020-06-18
InPen System (K201337)Companion Medical, Inc.2020-06-18
Medussa-PL Cage (K200283)Medyssey USA, Inc.2020-06-18
NavLock Trackers (K201327)Medtronic Navigation2020-06-18
Medline UNITE Jones Fracture Screw System (K201319)Medline Industires, Inc.2020-06-17
Aerus Medical Guardian,model F170A (K201220)Aerus Medical, LLC2020-06-17
AI-Rad Companion Brain MR (K193290)Siemens Medical Solutions USA, Inc.2020-06-17
Entuit Nasal Jejunal Feeding Tube (K201322)Wilson-Cook Medical, Inc.2020-06-17
qER (K200921)Qure.Ai Technologies2020-06-17
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System (K201029)Spinal Elements, Inc.2020-06-17
Yxoss CBR® (K192747)Reoss GmbH2020-06-17
LT Antibacterial Alginate with Silver Dressing (K192478)Zhejiang Longterm Medical Technology Co., Ltd.2020-06-17
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (K193253)Shenzhen Changkun Technology Co., Ltd.2020-06-17
Miru 1day UpSide (midafilcon A) (K193399)Menicon Co, Ltd.2020-06-17
INOmax DSIR Plus (K200389)Mallinckrodt Manufacturing, LLC2020-06-17
ArtiSential Laparoscopic Instruments - Electrodes (K200875)Livsmed, Inc.2020-06-17
Control-IQ Technology (K200467)Tandem Diabetes Care, Inc.2020-06-16
iTotal® Identity Posterior Stabilized Knee Replacement System (K201023)Conformis, Inc.2020-06-16
Spinal Fixation System (K190408)Shangdong Kangsheng Medical Devices Co., Ltd.2020-06-16
TRUMATCH Personalized Solutions (K193540)DePuy Orthopaedics, Inc.2020-06-16
Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde (K192542)Modern Medical Equipment Manufacturing, Ltd.2020-06-16
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Every clearance here is in the API, with alerts when new ones post.