Atlas FDA

2020

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

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RecordFirmDate
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head (K201399)Karl Storz-Endoscopy-America, Inc.2020-08-17
WallFlex Colonic Stent System with Anchor Lock Delivery System (K201159)Boston Scientific Corporation2020-08-17
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) (K200648)Ekos Corporation2020-08-17
RadGil2 (K201177)R3 X-Ray L.L.C2020-08-17
Sperm Freeze, Sperm Fridge (K192845)Kitazato Corporation2020-08-17
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (K193492)23AndMe, Inc.2020-08-17
Cytrans Granules (K192597)GC America, Inc.2020-08-17
Sirona Dental CAD/CAM System with CEREC Chairside Software (K193408)Dentsply Sirona2020-08-16
BracePaste Band and Build LC (K202276)American Orthodontics2020-08-14
Route 92 Medical 088 Access System (K201518)Route 92 Medical2020-08-14
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head (K191708)Signature Orthopaedics Pty, Ltd.2020-08-14
TOMTEC-ARENA (K201632)Tomtec Imaging Systems GmbH2020-08-14
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite (K201010)Nobio , Ltd.2020-08-14
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit (K200848)Micron Medical Corporation2020-08-14
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft (K200064)SurGenTec, LLC2020-08-14
The AIO Solution 3.0 (K202068)Orfit Industries NV2020-08-14
LOOP LED Curing Light System (K200775)Garrison Dental Solutions, LLC2020-08-14
Orthocem, Ortho Bite (K192682)Dentscare Ltda2020-08-14
AncestryDNA Saliva Collection Kit (K192947)Ancestry Genomics, Inc.2020-08-13
Cuffix (K192611)Biovo Technologies , Ltd.2020-08-13
Syngo.via RT Image Suite (K201444)Siemens Medical Solutions USA, Inc.2020-08-13
StimaWELL 120MTRS (K181645)Pierenkemper GmbH2020-08-13
Univers Revers Modular Glenoid System, Half Augment Baseplate (K200895)Arthrex, Inc.2020-08-13
Straumann® Retentive System – Novaloc TiN Abutments (K193046)Institut Straumann AG2020-08-13
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (K193429)Howmedica Osteonics Corp.2020-08-13
Braid (K200822)Braid.Health2020-08-13
Limbus Contour (K201232)Limbus Ai, Inc.2020-08-13
IlluminOss Photodynamic Bone Stabilization System (K201961)Illuminoss Medical, Inc.2020-08-13
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator (K201916)Sorin Group Italia S.R.L.2020-08-13
AncestryDNA Factor V Leiden Genetic Health Risk Test (K192944)Ancestry Genomics, Inc.2020-08-13
SpaceFlex Knee - 80mm Size (K201960)G21, S.R.L.2020-08-13
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (K200133)Safecare Biotech (Hangzhou) Co., Ltd.2020-08-13
Syringe Holder accessory (K201248)Vapocoolshot, Inc.2020-08-12
SOMNOscreen plus (K201054)Somnomedics GmbH2020-08-12
BD PhaSeal Optima Closed System Drug Transfer Device (K201099)Becton, Dickinson and Company2020-08-12
Tyece OTC TENS Model (K200838)Tyece Limited2020-08-12
SNA-001 Silver Photoparticle Topical Gel (K192620)Sienna Biopharmaceuticals, Inc.2020-08-12
VisualEyes (K200534)Interacoustics A/S2020-08-12
Aurora Evacuator +Coag (K201637)Rebound Therapeutics2020-08-12
TruDi Curette (K201174)Acclarent, Inc.2020-08-12
Surgical Mask (K201871)C & S Paper Yunfu Co., Ltd.2020-08-12
Orion (K200529)Interacoustics A/S2020-08-12
UNIKO PointCloud™ Knee Instruments (K193312)Unik Orthopedics, Inc.2020-08-12
Osteo-site Vertebral Balloon (K200763)Izi Medical2020-08-12
Pointe Scientific Creatinine Kinase (CK) Reagent Set (K191296)Medtest DX2020-08-11
OMNI PLUS Surgical System (K201953)Sight Sciences, Inc.2020-08-11
NuEra Tight, NuEra Tight EMS (K200359)Bios S.R.L.2020-08-11
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch (K201286)Nurse Assist, LLC2020-08-11
LION Photocoagulator (K201623)Norlase Aps2020-08-11
HD Video Rhino Laryngoscope (K200740)KARL STORZ Endoscopy-America, Inc.2020-08-11
Disposable High Speed Air Turbine Handpiece (K193264)Ningbo Hpdove Dental Instruments Co., Ltd.2020-08-11
Mega Plus MIS Spine System (K200981)Bk Meditech, Co., Ltd.2020-08-11
ImagenSPECT 3.0 (K201933)Cardiovascular Imaging Technologies2020-08-11
Lateralized Glenosphere (K193175)Medacta Inernational SA2020-08-11
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K201722)Hyperfine Research, Inc.2020-08-11
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice (K201588)Varian Medical Systems, Inc.2020-08-11
Precice® Bone Transport System (K201567)Nuvasive Specialized Orthopedics, Inc.2020-08-10
Monterey AL Interbody System (K201585)Stryker Corporation2020-08-10
GS Medical AnyPlus PEEK Cage System (K200592)GS Medical Co., Ltd.2020-08-10
Masimo Rad-97 Pulse CO-Oximeter and Accessories (K193626)Masimo Corporation2020-08-10
MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (K193006)Tonica Elektronik A/S2020-08-09
Accipiolx (K201310)Maxq AL , Ltd.2020-08-07
D-LUX+ (K200809)DiaDent Group International2020-08-07
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) (K201932)Careray Digital Medical System Co., Ltd.2020-08-07
ProSeal™ Closed System drug Transfer Device (CSTD) (K192075)Epic Medical Pte. , Ltd.2020-08-07
TaiChiA (K193207)Our United Corporation2020-08-07
VIDAvision (K200990)Vida Diagnostics, Inc.2020-08-07
CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) (K201067)Cupid Limited2020-08-07
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System (K201926)CarboFix Orthopedics , Ltd.2020-08-07
EndoTool IV System (K201619)Monarch Medical Technologies, LLC2020-08-07
Sterile High-pressure Angiographic Syringes for Single-use (K192657)Shenzhen Boon Medical Supply Co., Ltd.2020-08-07
MedSource CathMED IV Catheter (K193278)Medsource Labs2020-08-07
LZI Fentanyl II Enzyme Immunoassay (K201938)Lin-Zhi International, Inc.2020-08-07
MVP Aligner System (K193130)Mvp Aligners, LLC2020-08-07
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices (K201244)Transmed7, LLC2020-08-07
Fountain ValveTip Infusion Catheter (K193082)Merit Medical Systems, Inc.2020-08-07
Cell-Free DNA BCT (DEN200001)Streck, Inc.2020-08-07
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor (K201883)Medos International SARL2020-08-07
K2M Navigation Instruments (K201006)K2m, Inc.2020-08-07
Disposable Laparoscope Trocar (K201641)Beijing Biosis Healing Biolog Ical Technology Co., Ltd.2020-08-06
ManaFlow (K200353)Manamed, Inc.2020-08-06
ClariVein IC (K201907)Merit Medical Systems, Inc.2020-08-06
NHancer Rx (K200324)Imds Operations B.V.2020-08-06
Pentaray Nav eco High-Density Mapping Catheter (K201750)Biosense Webster, Inc.2020-08-06
Medina Anterior Cervical Plate System (K201521)Alliance Partners, LLC2020-08-06
Vitra 810 (K201502)Quantel Medical2020-08-06
Mini Sterilizable Tray (K200858)Implant Direct Sybron Manufacturing, LLC2020-08-06
Invacare Perfecto2V Oxygen Concentrator (K200890)Invacare Corporation2020-08-06
Steripack cases and Tray Systems (K193066)Avalign Technologies, Inc.2020-08-06
VICRYL Mesh (K201143)ETHICON, Inc.2020-08-06
TK Safety Needle (K191644)Anhui Tiankang Medical Technology Co., Ltd.2020-08-06
Anchor Dual Lumen Guidewire Catheter (K201076)Aqure Medical, Inc.2020-08-06
Midmark Extraoral Imaging System (EOIS) (K201667)Midmark Corporation2020-08-06
Modular Toga (K200977)Operating Room Innovations, Inc.2020-08-05
XBit Series Digital Color Doppler Ultrasound System (K200780)CHISON Medical Technologies Co., Ltd.2020-08-05
NADIA SI Fusion System (K190580)Ilion Medical, Inc.2020-08-05
Smart Toe II, X Fuse (K201715)Stryker GmbH2020-08-05
CrossGlide ETS Plus (K201952)Crossbay Medical2020-08-05
LATITUDE EV™ Total Elbow Arthroplasty (K193247)Tornier, Inc.2020-08-05
Spartan Hip Stem (K192883)Signature Orthopaedics Pty, Ltd.2020-08-05
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