510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,669
176,466 records, page 2636 of 3530
510(k) clearances, page 2636 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K890351Orthoralix Sd/orthoralix Sd CephPhilips North America LLCIZFClass II
K890171Inline Autotransfusion SystemConmedcorpCACClass II
K884759Shower Stretcher W/wheelsLinido, Inc.FPOClass II
K893444Argenco 46 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893443Argenco 60 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893442Argenco 58 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893441Argenco 50 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893434Argenco 20 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893433Personal Amplifier Model Ultra HelixElectone, Inc.ESDClass I
K893413Argenco 40 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893386Argenco 62 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893385Argenco 77 Type II Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893384Argenco 83 Type I Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893383Argenco 75 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893382Argenco 63 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893381Argenco 71 Type II Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K893345Argelite 50 (Dental Alloy for Porcelain Appli.)Argen Precious Metals, Inc.EJTClass II
K893266Latex Examination GlovesYi-Gang Machinery & Engineering Co., Ltd.LYYClass I
K893166Latex Examination GlovesGulfwin Holding Sdn. Bhd.LYYClass I
K893098Vinyl Exam Gloves (Mfg. Toplas Industrial Co.)Jason Co.LYZClass I
K893047Jasontex Latex Examination GlovesJasontex Co., Ltd.LYYClass I
K892965Latex Exam Gloves (Mfg. Broadland Rubber Indust.)Dmp, Inc.LYYClass I
K892961Patient Examination GlovesViratect, Inc.LYYClass I
K892945Patient Examination GlovesR.J.M. Precaution Products, Inc.LYYClass I
K892923Latex Patient Examination GlovesGigantic International Corp.LYYClass I
K892910Argelite 76Sf+ Dental AlloyArgen Precious Metals, Inc.EJTClass II
K892768Patient Examination Gloves (Poly)Promedica Products, Inc.LZAClass I
K892625Patient Examination Gloves (Latex)Hand Care, Inc., Ltd.LYYClass I
K892624Patient Examination Gloves (Latex)Sanital Co., Ltd.LYYClass I
K892456Kulzer Translux EcKulzer GmbHEBZClass II
K892264Oralchek Super-Soft BrushPfizer IncEFWClass I
K892220Laminaria TentBerkeley MedevicesHDYClass II
K891600Argedent 88, Dental Alloy for Porcelain)Argen Precious Metals, Inc.EJTClass II
K890424Enteral Feeding ContainerMulti-Med, Inc.KNTClass II
K893663Instant Eosin-AqueousShandon, Inc.HYBClass I
K893530Iristain Formula 2, Parts 1 and 2Intl. Remote Imaging SystemsJTSClass I
K893439Hemo-Cath Silicone Double Lumen Cath Sl28c & Sl40cMedical Components, Inc.LFJClass II
K892928Haemophilus Test Medium (Agar)Remel IncJSOClass II
K892802Super DuoMercia Diagnostics, Ltd.JWZClass I
K892645Amicon Vitafiber Flo-Path Biorect/vls Cell Cult SyAmicon, Inc.KJFClass I
K892205Danam Vector-8+Danam ElectronicsGKZClass II
K891906Robicsek Intracardiac Suction WandGish Biomedical, Inc.DTSClass II
K891680Lyphochek Tumor Marker Controls, Levels I and IIBio-RadJJYClass I
K890814Danek Ring Fixator (Drf)Danek Medical, Inc.KTTClass II
K885279Cutinova(r) Plus on Vascular Stasis UlcersBeiersdorf, Inc.FROUnclassified
K885211RF-100 Monitor, RF-P-2.5, RF-P-5, RF-P-7.5 ProbesRf Design Assoc., Inc.IYNClass II
K885091Hemaview Darkfield Microscope SystemTechnalysis, Inc.IBMClass I
K893544Handi Porch Elevator & Liberty Wheelchair LiftThe Cheney Co.INGClass II
K893503Sofsens(tm) Model Lmp-100 Intrauterine Pres. TransLaurel Medical Corp.HFNClass II
K893490Handi-Lift/victory Wheelchair LiftThe Cheney Co.INGClass II