Atlas FDA

2021

3,023 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ACUSON Sequoia Diagnostic Ultrasound System (K211859)Siemens Medical Solutions USA, Inc.2021-07-20
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray (K203765)Zirkonzahn Srl2021-07-20
LifeLens Wireless ECG Monitor (K203168)LifeLens Technologies, Inc.2021-07-20
Vital Signs (K211906)Oxehealth Limited2021-07-20
Elos® Intramedullary Nailing System (K201147)Intrauma S.P.A2021-07-19
ENNOVATE Spinal System (K210963)Aesculap Implant Systems, LLC2021-07-19
xvision Spine system (XVS) (K211188)Augmedics, Ltd.2021-07-19
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (K211291)Fiagon GmbH2021-07-19
Evolve System with the T3 Applicator (K210877)InMode , Ltd.2021-07-19
Z-6 Atrioseptostomy Catheter (K211910)NuMED, Inc.2021-07-19
POLARSTEM Calcar Reamer Guide (K211548)Smith & Nephew, Inc.2021-07-19
Vinyl Patient Examination Gloves (K211239)Jiangxi Shengda Medical Technology Co., Ltd.2021-07-17
Powder Free Vinyl Patient Examination Gloves (K211177)Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.2021-07-17
Medtronic Extended infusion set (K210544)Unomedical A/S2021-07-16
ExoAtlet-II (K201473)Exoatlet Asia Co. , Ltd.2021-07-16
SureMAX-SA Cervical Standalone System (K211111)Additive Implants, Inc.2021-07-16
Soniquence Reusable Bipolar Cable (K211946)Soniquence, LLC2021-07-16
Avanti Orthopaedics Ulnar Shortening System (K211592)Avanti Orthopaedics, Inc.2021-07-16
ADVIA Centaur® Digoxin assay (K193397)Siemens Healthcare Diagnostics, Inc.2021-07-16
SwiftNINJA Steerable Microcatheter (K211525)Merit Medical Systems, Inc.2021-07-16
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX (K210103)Lifelong Meditech Private Limited2021-07-16
Ignite Stemless Anatomic Shoulder System (K203108)Ignite Orthopedics, LLC2021-07-16
JS Dental Lab Mouth Guard (K210011)Ampower Dental Laboratories, LLC2021-07-16
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System (K203435)Nihon Kohden Corporation2021-07-16
PacBond One (K210186)Pac-Dent, Inc.2021-07-16
Velguard Surgical Face Mask (K210761)Esstee Exports Health Care Division2021-07-16
StitchKit (K211792)Origami Surgical Inc .2021-07-16
Pain Therapy Device (K202638)Guangzhou Xinbo Electronic Co., Ltd.2021-07-15
TERA HARZ (K202846)Graphy, Inc.2021-07-15
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (K211547)Edma Group, LLC2021-07-15
EleVation Breast Biopsy System (K211933)Bard Peripheral Vascular2021-07-15
Bio-Medicus Life Support Catheter and Introducer (K201100)Medtronic, Inc.2021-07-15
Disposable Procedural Ear-loop Face Mask (K211042)Changzhou Dsb Medical Co., Ltd.2021-07-15
Acumed Clavicle Hook Plating System (K210750)Acumed, LLC2021-07-15
Longeviti PorousFit implant (K211514)Longeviti Neuro Solutions, LLC2021-07-15
ReCross (K210431)Imds Operations B.V.2021-07-15
Crosstex VH2O2 Chemical Indicators (K200096)Crosstex International, Inc. (A Cantel Medical Company)2021-07-15
Dexcom G6 Continuous Glucose Monitoring (CGM) System (K201328)Dexcom, Inc.2021-07-15
Darwin (K203728)Luvo Medical Technologies, Inc.2021-07-14
OsteoSync™ Ti Dental Mesh (K202918)Sites Medical, LLC2021-07-14
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (K202304)Nyu Langone Medical Center2021-07-14
Bencox THR System (K211866)Corentec Co., Ltd.2021-07-14
Surgical Face Mask, Surgical Mask (K201844)Lear Corporation2021-07-14
Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine (K200983)Ningbo Hesi Electric Co., Ltd.2021-07-14
Pisces Spinal System (K203023)Ortho Development Corporation2021-07-14
Myopia Master (K202989)Oculus Optikgeräte GmbH2021-07-14
Nexo-Gide Bilayer Collagen Membrane (K203496)Geistlich Pharma AG2021-07-14
ARVIS Surgical Navigation System (K203115)Insight Medical Systems, Inc.2021-07-14
Aduro Light Beauty Mask (K202390)Shenzhen Kaiyan Medical CO , Ltd.2021-07-14
N Latex FLC kappa, N Latex FLC lambda (K193047)Siemens Healthcare Diagnostics Products GmbH2021-07-14
EliA SmDP-S (K202067)Phadia AB2021-07-14
Provident II Hip Stems (K201733)Globus Medical, Inc.2021-07-14
SMART FINDER (K203509)Ims Giotto S.P.A.2021-07-14
Finetest Lite Blood Glucose Monitoring System (K203562)Osang Healthcare Co. , Ltd.2021-07-13
Physica LMC Knee System (K211938)Limacorporate2021-07-13
ADVIA Centaur® Total hCG assay (K200210)Siemens Healthcare Diagnostics, Inc.2021-07-13
UltraTemp Rez II (K211237)Ultradent Products, Inc.2021-07-13
Electric Wheelchair [Models: JRWD6010/JRWD6012] (K192739)Jerry Medical Instrument (Shanghai) Co., Ltd.2021-07-13
RadiForce RX370 (K211491)Eizo Corporation2021-07-12
Disposable Medical Face Mask (K210244)Suzhou Bolisi Medical Technology Co., Ltd.2021-07-12
PowerLook Density Assessment V4.0 (K211506)Icad, Inc.2021-07-12
InSpace Subacromial Tissue Spacer System (DEN200039)Ortho-Space , Ltd.2021-07-12
Nitrile Patient Examination Glove (K210723)Jiangxi Zhonghong Pulin Medical Products Co., Ltd.2021-07-12
EOS PMP (K211495)Sorin Group Italia S.R.L.2021-07-12
Nitrile Examination Gloves (K210776)5r Med Instruments (Chengdu) Co., Ltd.2021-07-12
Bone Screws dia. 5,0 mm (K210717)Lima Corporate S.P.A.2021-07-12
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables (K203556)Medtronic, Inc.2021-07-12
Magneto Nasal Mask (K210386)Respironics, Inc.2021-07-12
InMode RF Pro System (K210492)Inmode MD , Ltd.2021-07-12
Zavation Spinal System (K211113)Zavation Medical Products, LLC2021-07-12
Medical Nitrile Examination Gloves (Power free, Blue) (K210578)Jiangxi Hongda Medical Equipment Group , Ltd.2021-07-10
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM (K200575)Truemed Group, LLC2021-07-09
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) (K201675)bioMerieux, Inc.2021-07-09
Monarch Platform (K211493)Auris Health, Inc.2021-07-09
Cytrellis Dermal Micro-Coring System (K202517)Cytrellis Biosystems, Inc.2021-07-09
BTL-899 FP (K211107)BTL Industries, Inc.2021-07-09
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs (K200915)Gx Corporation Sdn Bhd2021-07-09
Grosz Play Feel (K211088)Rb Health (Us), LLC2021-07-09
Microwave Therapeutic System (K201262)Nanjing Eco Microwave System Co., Ltd.2021-07-09
PRIMO S (K211542)A.T.S. Applicazione Tecnologie Speciali S.R.L.2021-07-09
Tamarin Blue PTCA RX Dilatation Catheter (K210012)Natec Medical , Ltd.2021-07-09
AortaSTAT Occlusion Device (K210602)Renalpro Medical, Inc.2021-07-09
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (K210607)Heraeus Medical GmbH2021-07-09
HM70 EVO Diagnostic Ultrasound System (K210713)Samsung Medison Co., Ltd.2021-07-09
Medical PVC Examination Gloves (K210821)Jiangxi Hongda Medical Equipment Group , Ltd.2021-07-09
Extreme X8 (K211574)Magic Mobility2021-07-09
PRE-SURE (K201835)Lazarus 3D, Inc.2021-07-08
Nebulizer Kit (K192971)Excellentcare Medical (Huizhou) , Ltd.2021-07-08
TruAbutment DS, TruBase (K202579)Truabutment, Inc.2021-07-08
Disposable Surgical Mask (K210267)Xiamen Eagledon Pharmaceutical Co., Ltd.2021-07-08
BioWave BioWraps (K203158)Biowave Corporation2021-07-08
Medical surgical mask (K210380)Shantou T&K Medical Equipment Factory Co.,Ltd2021-07-08
SensiTox C. difficile Toxin Test (K193490)First Light Diagnostics, Inc.2021-07-08
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform (K211465)Edwards Lfesciences2021-07-08
Nerve and Muscle Stimulator (K211094)Shenzhen Xft Medical Limited2021-07-08
iSR'obot Mona Lisa 1.0 (K203659)Biobot Surgical Pte., Ltd.2021-07-08
NubeX (K211480)Techheim Co., Ltd.2021-07-08
Ultra SEP (K210945)Reliance Orthodontic Products, Inc.2021-07-08
StealthStation Spinous Process Clamps (K211442)Medtronic Navigation2021-07-08
Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) (K203148)Ningbo Youhe Electrical Appliance Technology Co., Ltd.2021-07-08
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