Atlas FDA

2020

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

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RecordFirmDate
E-COM DR-2000 DR (K193644)Livermoretech, Inc.2020-02-14
TGS Universal Headrest with Mounting Arm (K193502)Stryker Ent2020-02-14
ArtiSential Bipolar Fenestrated Forceps (K190909)Livsmed, Inc.2020-02-13
XenoSure Biologic Patch (K190882)Lemaitre Vascular2020-02-13
NewPrim System (K191966)Brm Extremities2020-02-13
ClearPoint System and Accessories (K200079)Mri Interventions, Inc.2020-02-13
Youjia Unscented Tampon with Plastic Applicators (K192557)Qingdao Youjia Hygiene Technology Co., Ltd.2020-02-13
DiaTemp Flow (K192022)DiaDent Group International2020-02-13
Implacil Implant System (K183024)Implacil DE Bortoli Material Odontologico Ltda2020-02-13
Daytona® Small Stature Growth Rod Conversion Set (K193224)SeaSpine Orthopedics Corporation2020-02-13
DiaTemp (K192158)DiaDent Group International2020-02-13
Microlife Non-Contact Infrared Forehead Thermometer (K191829)Microlife Intellectual Property GmbH2020-02-13
Vathin Video Bronchoscope System (K191828)Hunan Vathin Medical Instrument Co., Ltd.2020-02-13
Agilon Moldable (K193168)Biogennix, LLC2020-02-13
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System (K192828)Canon Medical Systems Corporation2020-02-13
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K192614)Megagen Implant Co., Ltd.2020-02-13
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology (K193232)Covidien, LLC2020-02-13
Infinitt RT PACS (K193498)Infinitt Healthcare Co., Ltd.2020-02-13
ADVIA Centaur BR (K193489)Siemens Healthcare Diagnostics, Inc.2020-02-13
OrthoCircle Spine Pedicle Screw System (K193472)Orthocircle Spine2020-02-13
Praxiject 0.9% NaCl (K192414)Medxl, Inc.2020-02-13
EleGARD Patient Positioning System (K191689)Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio2020-02-13
LED Curing Light (K192233)Foshan Cicada Dental Instrument Co, Ltd.2020-02-13
Leltek Ultrasound Imaging System (K191235)Leltek, Inc.2020-02-12
Biograph Horizon (K193178)Siemens Medical Solution USA, Inc.2020-02-12
Acteon Imaging Suite (K192165)De Gotzen S.R.L.2020-02-11
CAPENERGY - C100, C200, C300, C400, C50 (K191202)Capenergy Medical S.L.2020-02-11
EzRay Air Portable (Model: VEX-P300) (K200182)VATECH Co., Ltd.2020-02-11
ULab Systems Dental Aligner Kit (K192596)Ulab Systems, Inc.2020-02-11
AcQMap High Resolution Imaging and Mapping System (K193013)Acutus Medical, Inc.2020-02-11
Cervitec F (K191453)Ivoclar Vivadent, AG2020-02-11
Argen Clear Aligner, Argen Clear Aligner Premium (K192846)Argen Corporation2020-02-10
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws (K193156)Arthrex, Inc.2020-02-10
JO for Him H2O Gel Original Personal Lubricant (K192203)United Consortium2020-02-10
M.U.S.T. MINI Posterior Cervical Screws System (K200130)Medacta International S.A.2020-02-10
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon (K192377)Varian Medical Systems, Inc.2020-02-10
Elos Accurate Hybrid Base (K191919)Elos Medtech Pinol A/S2020-02-10
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System (K200065)Roche Molecular Systems, Inc.2020-02-10
InPen System (K192841)Companion Medical, Inc.2020-02-10
Sutter Swyng non-stick bipolar forceps, single-use (K193587)Sutter Medizintechnik GmbH2020-02-10
Dermadry (K192749)Dermadry Laboratories, Inc.2020-02-10
K3Pro Konus New Abutments and Implants (K190192)Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG2020-02-10
Surfacer Inside-Out Access Catheter System (DEN190038)Bluegrass Vascular Technologies, Inc.2020-02-10
MectaFix CL Fixation Button with Continuous Loop (K193165)Medacta International S.A.2020-02-10
Vesta RF Cannula (K190259)Biomerics2020-02-07
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit (K192273)DiaDent Group International2020-02-07
Elefix V Paste for EEG & EMG (K191975)Nihon Kohden Corporation2020-02-07
Rochal Antimicrobial Wound Gel (K192527)Rochal Industries, LLC2020-02-07
NeoBase 2 Non-derivatized MSMS Kit (K193103)Perkinelmer, Inc.2020-02-07
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183688)Abbott Point of Care, Inc.2020-02-07
Caption Guidance (DEN190040)Bay Labs, Inc.2020-02-07
Paragon XHD Diagnostic Ultrasound System (K191347)Shenzhen Wisonic Medical Technology Co. , Ltd.2020-02-07
3M Attest Super Rapid 5 Steam-Plus Challenge Pack (K193154)3M Company2020-02-07
Yukon OCT Spinal System (K193129)K2m, Inc.2020-02-07
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183678)Abbott Point of Care, Inc.2020-02-07
i-STAT CHEM8+ cartridge with the i-STAT 1 System (K191298)Abbott Point of Care, Inc.2020-02-07
Pulmonary Cytology Brush (K182927)Hobbs Medical, Inc.2020-02-07
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack (K191416)Caldera Medical, Inc.2020-02-07
Trevo NXT ProVue Retriever (K200117)Stryker2020-02-07
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (K190800)Cosmed Srl2020-02-06
UV Radiation Treatment System (K191571)Xuzhou Yongkang Electronic Science Technology Co., Ltd.2020-02-06
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 (K192757)Vitalconnect, Inc.2020-02-06
Lucy Point-of-Care Magnetic Resonance Imaging Device (K192002)Hyperfine Research, Inc.2020-02-06
Steerable Plateau Ti (K193521)Life Spine, Inc.2020-02-06
Elos Accurate Customized Abutment (K191890)Elos Medtech Pinol A/S2020-02-06
BreathID Smart System (K193610)Exalenz Bioscience , Ltd.2020-02-06
MectaLock All-Suture Anchors (K193461)Medacta International S.A.2020-02-06
Ancora Nerve Block Catheter Set (K191290)Ancora Medical Technology2020-02-06
da Vinci Xi Surgical System, da Vinci X Surgical System (K191529)Intuitive Surgical2020-02-06
Ah!Yes Ob Coco Personal Lubricant (K191411)Bio-Tech Lubricants, Ltd.2020-02-06
PERLA® TL posterior osteosynthesis system (K193396)Spineart2020-02-05
DENTCA Crown and Bridge (K192806)Dentca, Inc.2020-02-05
Respire Pink AT (Hard, Hard/Soft, EF) (K192127)Respire Medical Holdings2020-02-05
OptiScanner® 5000 Glucose Monitoring System (K192785)Optiscan Biomedical Corporation2020-02-05
Endosee System (K200038)CooperSurgical, Inc.2020-02-05
Infinity / Infinity Cross Flex Dental Systems (K180935)Olsen Industria E Comercio S.A.2020-02-05
SpineNet SSP System (K200170)Spinenet, LLC2020-02-05
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System (K193320)Kyocera Medical Technologies, Inc.2020-02-04
Akesis Galaxy RTx (K200050)Akesis, Inc.2020-02-04
Summit DuoFix HA Coating (K193398)DePuy Orthopaedics, Inc.2020-02-04
The Caterpillar and Caterpillar Micro Arterial Embolization Devices (K191532)C.R. Bard, Inc.2020-02-04
s-Clean SQ-SL Implant System Regular (K192688)Dentis Co., Ltd.2020-02-04
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) (K191832)Kurin, Inc.2020-02-04
OKLand Patient Return Electrode Pad (K183148)Auckland Medical Polymer(Tianjin) Co., Ltd.2020-02-04
Motion Correction System (K193324)Kineticor, Inc.2020-02-04
X-Guide Surgical Navigation System (K192579)X-Nav Technologies, LLC2020-02-03
Bella-mu (K190962)U-Needle B.V.2020-02-03
Comus Locking Plate systems (K190842)Jiangsu Trauhui Medical Instrument Co., Ltd.2020-02-03
Katalyst Training System (K190966)Katalyst, Inc.2020-02-03
Mako Total Hip Application (K193128)Mako Surgical Corp.2020-02-02
Optima Coil System (K200030)Balt USA, LLC2020-02-01
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia (K192535)Qinhuangdao Audental Metal Technology Co., Ltd.2020-01-31
CapLOX II®/TowerLOX® MIS Pedicle Screw System (K193270)Captiva Spine, Inc.2020-01-31
ActiPatch (K192234)Bioelectronics Corporation2020-01-31
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support (K191539)Rapid Biomedical GmbH2020-01-31
ACUSON Sequoia Diagnostic Ultrasound System (K193257)Siemens Medical Solutions USA, Inc.2020-01-31
TTC Phantom® Intramedullary Nail System (K192163)Paragon 28, Inc.2020-01-31
Tamper Evident Cap (K193192)International Medical Industries, Inc.2020-01-31
Physica LMC Knee System (K193284)Lima Corporate S.P.A.2020-01-31
ProLift Expandable System (K193258)Life Spine, Inc.2020-01-31
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Every clearance here is in the API, with alerts when new ones post.