Atlas FDA

2023

3,346 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Dexcom G6 Continuous Glucose Monitoring (CGM) System (K223931)Dexcom, Inc.2023-01-11
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate (K222181)Iconic Medicare Sdn Bhd2023-01-11
DD Solid Connect® CAD/CAM Abutments (K191111)Dental Direkt GmbH2023-01-11
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (K223719)Aegis Spine, Inc.2023-01-11
Metal Cannulated Screw (K221090)Double Medical Technology, Inc.2023-01-10
Haymaker® Screw System (K222799)Orthocircle Spine D.B.A. OC Medical Devices2023-01-10
ISAAC Neurovascular Navigation Catheter (K222115)MicroVention, Inc.2023-01-10
CoCr Head (K211047)Zimmer GmbH2023-01-10
HS186B Scooter (K222711)Suzhou Master Machinery Manufacturing Co.,Ltd2023-01-09
21HQ513D (K223789)Lg Electronics.Inc2023-01-09
Bone Cement Genta, Bone Cement HV, Bone Cement LV (K211163)Tecres S.P.A.2023-01-09
Vitrea Software Package, VSTP-002A (K223336)Canon Medical Systems Corporation2023-01-09
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P (K222787)Chongqing Sunkingdom Medical Instrument Co., Ltd.2023-01-09
VADER® Pedicle System, G21 Cement (K222789)Icotec AG2023-01-09
WatchPAT ONE (WP1) (K223675)Itamar Medical , Ltd.2023-01-06
Curiteva Navigation System (K223200)Curiteva, Inc.2023-01-06
LumiVy™ Lumbar IBF System (K223412)Vy Spine, LLC2023-01-06
BLUEDIAMOND IMPLANT, Abutment Screw (K211812)Megagen Implant Co., Ltd.2023-01-06
T3 Platform software (K213423)Etiometry, Inc.2023-01-06
U by Kotex® Click® Unscented Menstrual Tampons (K223749)Kimberly-Clark Corporation2023-01-06
Disposable Surgical Face Mask (K203380)Shandong Pop Jeans Intelligent Manufacturing Co., Ltd.2023-01-06
ARTICUL/EZE Ceramic Heads (K222296)Depuy Ireland UC2023-01-06
CSF-3 (K221260)Cardiacsense2023-01-06
TECHFIT Diagnostic Models (K222577)Techfit Digital Surgery, Inc.2023-01-06
Cervical Spine Truss System (CSTS) Interbody Fusion Device (K221266)4Web Medical, Inc.2023-01-05
Treace Medical Concepts (TMC) Plating System (K221181)Treace Medical Concepts, Inc.2023-01-05
CONDUIT LLIF Straight Inserters (K223671)Enztec Limited2023-01-05
REMEDY Stemmed Knee Spacer (K223650)Osteoremedies, LLC2023-01-05
Ax-Surgi Surgical Hemostat (K213198)Advamedica, Inc.2023-01-05
U-Motion II Acetabular System-Extension line (K221149)United Orthopedic Corporation2023-01-05
DEKA HELIX (K222221)El.En Electronic Engineering Spa2023-01-04
SilentCloud (K221125)Aureliym GmbH2023-01-04
Surgical Face Mask (K222483)Hubei Woozon Healthcare Co., Ltd.2023-01-04
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K222907)Rmkh Glove (Cambodia) Co., Ltd.2023-01-04
SmoothCool HR System (K223685)Jeisys Medical, Inc.2023-01-04
Wearable Breast Pump (Model S1DW) (K222045)Shenzhen TPH Technology Co., Ltd.2023-01-04
Radial Artery Compression Tourniquets (K222182)Beijing Demax Medical Technology Co.,Ltd2023-01-04
Steriking LT-Blueline Pouches with Tyvek (K221379)Wipak OY2023-01-04
Elecsys Anti-HCV II (08837031190) (K221693)Roche Diagnostics2023-01-04
OnyxCeph (K213263)Image Instruments GmbH2023-01-04
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (K223635)Sienco, Inc.2023-01-04
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (K223411)Xiamen Probtain Medical Techology Co., Ltd.2023-01-04
Medical Disposable Face Masks (K222809)Anqing Mayfield Medical Limited2023-01-03
EZ-STIK Electrodes (K223775)South Dakota Partners2023-01-03
AETOS Shoulder System (K220847)Smith & Nephew, Inc.2023-01-03
3.0T 16ch AIR AA (K223378)Ge Healthcare Coils (Usa Instruments, Inc.)2023-01-03
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Every clearance here is in the API, with alerts when new ones post.