Atlas FDA

2020

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

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RecordFirmDate
da Vinci X and Xi Surgical System (K183086)Intuitive Surgical, Inc.2020-03-31
SI-BONE iFuse Implant System® (K193524)SI-BONE, Inc.2020-03-31
T-Line Hernia Mesh (K193144)Deep Blue Medical Advances, Inc.2020-03-30
System 83 Plus Washer/Disinfector (K173590)Custom Ultrasonics, Inc.2020-03-30
Universal Base Conical Connection (CC) (K200040)Nobel Biocare AG2020-03-30
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch (K192490)Teleflex Medical2020-03-30
NuVasive Cohere Thoracolumbar Interbody System (K193541)Nu Vasive, Incorporated2020-03-30
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump (K192640)Guangzhou Yongyi Industrial Co., Ltd.2020-03-30
Agilon Strip (K193487)Biogennix, LLC2020-03-30
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (K200494)GE Healthcare2020-03-29
QuickDraw Venous Cannula (K200499)Edwards Lifesciences, LLC2020-03-29
Torc Body (K192039)Johari Digital Healthcare Limited2020-03-29
MRI ECG Patient Cable (K192852)Ivy Biomedical Systems, Inc.2020-03-28
uMR Omega (K193200)Shanghai United Imaging Healthcare Co., Ltd.2020-03-27
BiWaze Cough (K191912)Abmrc, LLC2020-03-27
CUBEScan BioCon-1100 (K200548)Mcube Technology Co., Ltd.2020-03-27
PregSense (K191401)Nuvo- Group , Ltd.2020-03-27
JJ Series Container System (K192056)Aesculap, Inc.2020-03-27
StimRouter Neuromodulation System (K200482)Bioness, Inc.2020-03-27
SkyPulse (K193656)Fotona D.O.O.2020-03-27
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) (K192389)Medtronic, Inc.2020-03-27
Diapaste (K190091)DiaDent Group International2020-03-27
Single Use Grasping Forceps (K191900)Zhejiang Chuangxiang Medical Technology Co., Ltd.2020-03-27
HBP6 Settable, Resorbable Hemostatic Bone Paste (K193052)Orthocon, Inc.2020-03-27
RAPIDPoint 500e Blood Gas System (K192240)Siemens Healthcare Diagnostics, Inc.2020-03-27
GrandioSO Light Flow (K200294)Voco GmbH2020-03-27
Silhouette Instalift (K200140)Silhouette Lift, Inc.2020-03-27
Stryker Facial iD Plating System (K193143)Stryker2020-03-26
gammaCore Sapphire (K191830)Electrocore, Inc.2020-03-26
AbClose - Port Site Closure Device (K193652)Medeon Biodesign, Inc.2020-03-26
Propeller Sensor for Symbicort (K192724)Reciprocal Labs Corporation2020-03-26
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (K191749)Novus Scientific AB2020-03-26
GEO 1st MTP Joint Arthrodesis Plating System (K200108)Gramercy Extremity Orthopedics, LLC2020-03-26
Bonecam Suture Anchor (K193108)Valeris Medical, Inc.2020-03-26
APTUS® Ankle Trauma System 2.8/3.5 (K193633)Medartis AG2020-03-26
Becker External Drainage and Monitoring System (K200456)Medtronic, Inc.2020-03-26
Tina-quant Hemoglobin A1cDx Gen.3 (K193053)Roche Diagnostics Operations (Rdo)2020-03-26
Konan Specular Microscope XVII (K191558)Konan Medical, Inc.2020-03-26
Stryker Customized Mandible Recon Plate Kit (K193136)Stryker2020-03-26
Aina HbA1c Monitoring System 2 (K192987)Jana Care, Inc.2020-03-26
BodyGuardian Remote Monitoring System (K192732)Preventice Technologies, Inc.2020-03-26
APTUS® Foot 2.8-3.5 System (K193639)Medartis AG2020-03-26
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K192886)Volcano Corporation2020-03-26
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun (K192951)Ellipse A/S2020-03-26
KOSMOS (K193518)EchoNous, Inc.2020-03-26
FINE Osteotomy around the knee (K193614)Bodycad Laboratories, Inc.2020-03-25
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (K192144)ETHICON, Inc.2020-03-25
IPL + Diode Laser Machine (K193328)Beijing Globalipl Development Co., Ltd.2020-03-25
CrossBay Endometrial Tissue Sampler (ETS) (K192534)Crossbay Medical2020-03-25
Arterys MICA (K192437)Arterys, Inc.2020-03-25
LightWalker Laser System Family (K193661)Fotona D.O.O.2020-03-25
MammoScreen (K192854)Therapixel2020-03-25
Aluna (K193311)Knox Medical Diagnostics, Inc.2020-03-25
Shapiro MD model laser 272 (K193667)Conversion Labs, Pr, LLC2020-03-25
Disposable NIBP Cuff (K193629)Shenzhen Changke Connect Electronics Co., Ltd.2020-03-25
NuVasive 3DP Interfixated ALIF System (K193593)Nu Vasive, Incorporated2020-03-25
MIS CONNECT Conical Connection System (K193078)Dentsply Sirona2020-03-25
syngo.CT Cardiac Planning (K200515)Siemens Medical Soultions USA, Inc.2020-03-25
Cry-Ac®, Cry-Ac-3®, Cry-Baby (K193619)Brymill Cryogenic Systems2020-03-25
NorthStar™ OCT Spinal System (K193615)SeaSpine Orthopedics Corporation2020-03-25
DiaFil Flow (K192284)DiaDent Group International2020-03-25
LaserShot M, NaviLase (K192008)Vitrolife GmbH2020-03-25
Medacta Shoulder System (K192967)Medacta International S.A.2020-03-25
TempSure System (K200241)Cynosure, LLC2020-03-25
Sherlock (K193335)Open Implants, LLC2020-03-24
SEA-LINK Anterior Cervical Plate System (K200224)Indius Medical Technologies Pvt. , Ltd.2020-03-24
FloPatch (FP120) (K200337)Flosonics Medical (R/A 1929803 Ontario Corp.)2020-03-24
Persona Personalized Knee System (K200209)Zimmer, Inc.2020-03-24
RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System (K193100)OrthoPediatrics Corp.2020-03-24
Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (K193145)Megadyne Medical Products, Inc.2020-03-24
PlasmaBlade X 3.0S LIGHT (K193579)Medtronic Navigation2020-03-24
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC (K191763)CooperVision, Inc.2020-03-23
RadiForce RX1270, RadiForce RX1270-AR (K200485)Eizo Corporation2020-03-23
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (K200543)Nexxt Spine, LLC2020-03-23
TruDi Probe (K193453)Acclarent, Inc.2020-03-23
Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range (K200043)Field Orthopaedics Pty, Ltd.2020-03-23
HepaShield Bacterial Viral Breathing System Filter (K191909)Flexicare Medical Limited.2020-03-23
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit (K200436)Hologic, Inc.2020-03-23
Sternal Cable System (K193479)A & E Medical Corporation2020-03-23
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (K191788)Medtronic Sofamor Danek USA, Inc.2020-03-23
Somryst (K191716)Pear Therapeutics, Inc.2020-03-23
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover (K200493)Stryker Corporation2020-03-21
AZUR Vascular Plug (K191680)MicroVention, Inc.2020-03-20
AI-ECG Tracker (K200036)Shenzhen Carewell Electronics Co., Ltd.2020-03-20
MTS Omadacycline 0.002 - 32 ug/mL (K200180)Liofilchem s.r.l.2020-03-20
EnlightenVue Microendoscopy System (K192300)Enlightenvue, Inc.2020-03-20
icotec Cervical Cage (K192897)Icotec AG2020-03-20
Hepatic VCAR (K193281)GE Medical Systems SCS2020-03-20
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K193121)Eco Medi Glove Sdn. Bhd.2020-03-20
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (K193183)Acist Medical Systems, Inc.2020-03-20
Clearform Aligners (K191838)Motor City Lab Works2020-03-20
DIAFIL & DIAFIL Capsule (K192510)DiaDent Group International2020-03-20
MULTIX Impact (K193089)Siemens Medical Solutions USA, Inc.2020-03-20
T2 ICF (K193366)Stryker GmbH2020-03-20
Nano FortiFix® System (K193211)Nanovis Spine, LLC2020-03-20
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve (K193327)Cardinal Health200, LLC2020-03-20
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner (K193560)Materialise NV2020-03-20
Q Switched Nd: YAG Laser machine (K193609)Beijing Lead Beauty S & T Co., Ltd.2020-03-20
Symbia 6.7 (K200474)Siemens Medical Solutions USA, Inc.2020-03-20
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster (K193581)Sri Trang Gloves (Thailand) Public Company Limited2020-03-20
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Every clearance here is in the API, with alerts when new ones post.