Atlas FDA

2019

2,918 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use (K183665)Jiangsu Micsafe Medical Technology Co., Ltd.2019-09-06
AcQMap High Resolution Imaging and Mapping System (K191392)Acutus Medical, Inc.2019-09-06
SmarTemp X1 (K190930)Parkell, Inc.2019-09-05
bili-hut (K190899)Little Sparrows Technologies, Inc.2019-09-05
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (K191343)STERIS Corporation2019-09-05
Holinwon 30 (K183563)Wontech Co., Ltd.2019-09-05
3M Clarity Aligners (K192119)3M Company2019-09-05
Persona Revision Knee System (K191625)Zimmer, Inc.2019-09-05
GM501 Wash (K190383)Hamilton Thorne, Inc.2019-09-05
FlowTriever Retrieval/Aspiration System (K191710)Inari Medical2019-09-05
FUJIFILM Ultrasonic Endoscope (K183433)Fujifilm Corporation2019-09-05
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label (K192020)STERIS Corporation2019-09-05
Dual-Safety Pen Needle (K191853)Promisemed Hangzhou Meditech Co., Ltd.2019-09-05
Advocate Non-Contact Infrared Thermometer (K191004)Broadmaster Biotech, Corp.2019-09-05
Freedom Primary PCK (K192148)Maxx Orthopedics, Inc.2019-09-05
EVIS EXERA III Bronchovideoscope Olympus BF-XT190 (K183419)Olympus Medical Systems Corp.2019-09-05
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (K192123)Qingdao Hightop Biotech Co., Ltd.2019-09-05
Smith & Nephew DYONICS 25 Fluid Management System (K192155)Smith & Nephew, Inc.2019-09-04
Opus Bulk Fill APS, Opus Bulk Fill Flow APS (K190758)Dentscare Ltda2019-09-04
GOLNIT Non-aborbable PTFE Surgical Suture (K192088)Antarma, LLC Dba Golnit Sutures2019-09-04
MTS Imipenem 0.016-256 µg/mL (K191908)Liofilchem s.r.l.2019-09-04
VPS Impression Material (K191034)Hygedent, Inc.2019-09-04
MobileRay Pulse SE Digital Imaging System (K191503)Portavision Medical, LLC2019-09-04
Signia Small Diameter Reloads (K191070)Covidien2019-09-04
Cartiva SCI instrumentation set (K192156)Cartiva, Inc.2019-09-04
Human IgA liquid reagent kit for Use on SPAPlus (K192116)The Binding Site Group , Ltd.2019-09-04
Akesis Galaxy (K190844)Akesis, Inc.2019-09-04
K3 (K183347)Osstem Implant Co., Ltd.2019-09-04
Myo Plus (K191179)Otto Bock Healthcare Products GmbH2019-09-04
Syntec Tibial Nail System (K191617)Syntec Scientific Corporation2019-09-03
NuVasive® ACP System (K191500)Nu Vasive, Incorporated2019-09-03
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe (K182765)Top Corporation2019-09-03
AcQRef Introducer Sheath (K192106)Acutus Medical, Inc.2019-09-03
Geomed Vascular Dilators (K183438)Geomed Medizin-Technik GmbH & Co.2019-09-03
Artemis Eye System (K190719)Penumbra, Inc.2019-08-30
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head (K190449)Olympus Medical Systems Corp.2019-08-30
Lumipulse G whole PTH (K190702)Fujirebio Diagnostics,Inc.2019-08-30
OPERA, OPERA eco (K190810)Unimom.Co2019-08-30
ReliefBand (K191547)Reliefband Technologies, LLC2019-08-30
EV1000 Clinical Platform NI, EV1000 Clinical Platform (K192058)Edwards Lifesciences, LLC2019-08-30
Triton Cage (K183407)Medyssey USA, Inc.2019-08-30
SelectFlex 072 Neurovascular Access System (K191664)Q'Apel Medical2019-08-30
iNSitu Total Hip System (K192071)Theken Companies, LLC2019-08-30
Carnation Ambulatory Monitor (K191471)Bardy Diagnostics, Inc.2019-08-30
Sutter RaVoR Bipolar Electrodes (K191732)Sutter Medizintechnik GmbH2019-08-30
Signature ONE System (K192074)Orthosoft Inc (D/B/A Zimmer Cas)2019-08-30
Pathfinder Endoscope Overtube (K191415)Neptune Medical, Inc.2019-08-30
Cyclops™ Anterior Cervical Plate System (K191786)Degen Medical, Inc.2019-08-30
LightWalker Laser System Family (K191554)Fotona D.O.O.2019-08-30
T1-CS, T1-C (K183475)Osstem Implant Co., Ltd.2019-08-30
Yumizen C1200 ALP, Yumizen C1200 Albumin (K191245)HORIBA ABX SAS2019-08-30
O2Vent Optima (K190236)Oventus Manufacturing Pty, Ltd.2019-08-29
Endoskeleton TAS Plate (K192054)Titan Spine, Inc.2019-08-29
D2P (K183489)3D Systems, Inc.2019-08-29
Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity (K191159)Invacare Corporation2019-08-29
Spine & Trauma Navigation (K183605)Brainlab AG2019-08-29
EvaQMax Smoke Evacuation System (K192035)Bio Protech, Inc.2019-08-29
gel-e Flex+ (K182811)Gel-E, Inc.2019-08-29
SGS Dental Implants System (K182219)Sgs International, Ltd.2019-08-29
Clarius Ultrasound Scanner (K192107)Clarius Mobile Health Corp.2019-08-29
Yushan X-Ray Flat Panel Detector (K191939)Innocare Optoelectronics Corp.2019-08-29
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate (K191475)Nobel Biocare AB2019-08-29
OverStitch 2-0 Polypropylene Suture (K191439)Apollo Endosurgery2019-08-29
Binary® Anterior Cervical Plate System (K192076)Genesys Spine2019-08-29
Voluson E6, Voluson E8, Voluson E10 (K192159)GE Healthcare2019-08-29
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink (K182382)Gmp Medicare Sdn Bhd (F25)2019-08-29
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) (K190744)Olympus Winter & Ibe GmbH2019-08-29
BD MAX Check-Points CPO (K190613)Check-Points Health B.V.2019-08-29
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (K190205)Edwards Lifesciences, LLC2019-08-29
Dunamis Fixation Button System (K191319)Dunamis, LLC2019-08-29
ClotTriever Thrombectomy System (K192036)Inari Medical2019-08-29
Omni Hysteroscope, Omni Lok cervical seal (K191281)Hologic, Inc.2019-08-29
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal (K192042)Geistlich Pharma AG2019-08-29
PureLift (K190269)Xtreem Pulse, LLC2019-08-28
Curiteva Pedicle Screw System (K191810)Curiteva, Inc.2019-08-28
Conformis BeneFIT Hip System (K190904)Conformis, Inc.2019-08-28
Omnia Medical VBR (K191778)Omnia Medical, LLC2019-08-28
Implantcast ic-Bipolar Head System (K191569)Implantcast GmbH2019-08-28
EXETER Centralizer, EXETER 2.5mm Plug (K191414)Stryker Orthopaedics2019-08-28
FEMME Applicator Tampon (K182142)Jiangsu Yoai Technology Co., Ltd.2019-08-28
BIOLOX CONTOURA Ceramic Femoral Head (K191399)Total Joint Othopedics, Inc.2019-08-28
AP50/30 Insufflator with Insuflow Port (K191780)Lexion Medical, LLC2019-08-28
Signature Ceramic Femoral Head (K190704)Signature Orthopaedics Pty, Ltd.2019-08-28
B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter (K182401)Amzetta Technologies Private Limited2019-08-28
CryoVizion System (K183485)Cryos Technologies, Inc.2019-08-28
Interphalangeal Joint Fusion Device Range (K191424)Neosteo2019-08-28
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533)Siemens Healthcare Diagnostics, Inc.2019-08-28
Delta 3300 (K190437)Netech Corporation2019-08-28
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor (K191077)Medtronic, Inc.2019-08-27
Plexus (K191107)Alleva Medical (D.G), Ltd.2019-08-27
AXIOS Stent and Electrocautery Enhanced Delivery System (K192043)Boston Scientific Corporation2019-08-26
IPS e.max CAD Abutment Solutions- extra systems (K191382)Ivoclar Vivadent, AG2019-08-26
Navigated T2 STRATOSPHERE Inserters and Navigated Templates (K191039)Medtronic Sofamor Danek USA, Inc.2019-08-26
Halley resin system (K191427)Dentsply Sirona2019-08-26
810nm Diode Laser System (K183122)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2019-08-25
1-Step Culture Medium (K191063)Shenzhen Vitavitro Biotech Co., Ltd.2019-08-23
OSW Aligner System (K191990)Osw Manufacturing, LLC2019-08-23
FUJIFILM Bronchoscope (K183607)Fujifilm Corporation2019-08-23
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (K191177)Smith and Nephew, Inc.2019-08-23
CustMBite Dental Guard (K183315)Dental Choice Holdings, LLC2019-08-23
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Every clearance here is in the API, with alerts when new ones post.