510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 1550 of 3531
510(k) clearances, page 1550 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K020117Gc Fuji Lining Lc Paste PakGC America Inc.EMAClass II
K020115Pulpdent Sealant/paste Orthodontic Bracket Adhesive SystemPulpdent CorporationDYHClass II
K020023Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone Pgr 636, Antibody for Immunoenzymatic StainingDako Corp.MXZClass II
K014295Stat Profile Phox AnalyzerNova Biomedical CorporationCHLClass II
K014203Abx Micros 60 Hematology AnalyzerHoriba Instruments IncorporatedGKXClass II
K014142Unite Bonding Adhesive3M UNITEK CorporationDYHClass II
K014112Satari Latex Patient Examination Powdered Glove Single Side Polymer Coated, Non Sterile, 200 Mg or Less of Total Water ESiam Sempermed Corp., Ltd.LYYClass I
K014110Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Polymer Coated WhitSiam Sempermed Corp., Ltd.LYYClass I
K014047Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources CorpGCJClass II
K013963Model 9210 Delivery Catheter, Model 9210Medtronic, Inc.DQYClass II
K013954Lorenz Self Drilling ScrewsBiomet MicrofixationHWCClass II
K013952Intuitive Surgical Stero View Endoscopic SystemIntuitive Surgical, Inc.GCJClass II
K013951Sandhill Scientific Pediatec Ph ProbeDiversatek Healthcare IncFFTClass I
K013819Urine Collection, Preservation and Transport SystemSierra Diagnostic, LLCJTWClass I
K013148Biogenex Monoclonal Anti-Estrogen Receptor(clone Er88)Biogenex Laboratories, Inc.MYAClass II
K012975Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision Control SolutionsAbbott MedicalNBWClass II
K012640Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsMedical Instruments Technology, Inc.HRXClass II
K012633Respironics Heated HumidifierRespironics, Inc.BTTClass II
K012357Ca 15-3 Assay for the Advia Centaur SystemBayer Diagnostics Corp.MOIClass II
K020463Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.GEXClass II
K020338Stealthstation with Fluoromerge SoftwareMedtronic Navigation, IncHAWClass II
K020291Exactech, Model Pmma Femoral Stem CentralizerExactech, Inc.JDIClass II
K020288Padpro, Model 2603Padpro, LLCMKJClass III
K0141151St Response Manual Resuscitator, Model 85XxAbbott MedicalBTMClass II
K014059Pulpdent Trans Oba Orthodontic Bracket AdhesivePulpdent CorporationDYHClass II
K013990Lifestitch Suturing DeviceEdwards Lifesciences LLCGATClass II
K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.NEYClass II
K013941Pulsion Fs Laser KeratomeIntra Lase Corp.GEXClass II
K013651Intergard Hemabridge Collagen Coated Vascular Prosthesis, Intergard Aortic Arch Collagen Coated Vascular ProsthesisIntervascular, Inc.DSYClass II
K013216Diodent Dental Laser SystemContinuum Electro-Optics, Inc.GEXClass II
K020493Syntex Powder-Free Nitrile Examination GloveSyntex Healthcare Products Co., Ltd.LZAClass I
K020426Msd Wire SystemMedtronic Sofamor DanekKWPClass II
K020352Surgical Dynamics Ogden Suture Anchor with SutureUnitedstates SurgicalHWCClass II
K020351D 903 Avant 2 Ph.i.s.i.o. Adult Hollow Fiber OxygenatorDideco S.p.A.DTZClass II
K020214Medial Rotation Knee SystemEngineering Consulting Services, Inc.JWHClass II
K020132Chase Cardiovascular Patch KitChase Medical, Inc.DXZClass II
K020044Vinyl Examination Gloves Sterile PowederedPrimus Gloves Private Ltd.LYZClass I
K013996Latex Powderfree Sterile Examination Gloves, Models-Extra Small, Small, Medium, Large, Extra LargeP.T. Maja Agung LatexindoLYYClass I
K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted (Visibility And/or Cosmetic) with UV BlocJohnson & Johnson Vision Care, Inc.LPLClass II
K013953Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein Labeling ClaimSupermax Glove Manufacturing Sdn BhdLYYClass I
K013940Laser System YellowstarAsclepion-Meditec AGGEXClass II
K013361Win-2 Tango Elite NpDurable Medical Equipment, Inc.ITIClass II
K013107Bioabsorbable Interference Screw MegafixKarl Storz Endoscopy-America, Inc.HWCClass II
K010798Rusch Cantor TubeRusch Intl.KNTClass II
K010797Rusch Miller-Abbott TubeRusch Intl.KNTClass II
K014201Aaron Reusable Electrosurgical ElectrodeApyx Medical CorporationGEIClass II
K013923Titanium Retrograde Femoral Nail - 13 Mm DiameterBiomet Orthopedics, Inc.HSBClass II
K013212Wavelenght Ultrasound LotionNational Therapy Products Inc.MUIClass II
K020436Portable X-Ray Units; Models Sp-HF-2.8 & Sp-HF-4.0Sedecal S.A.IZLClass II
K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.GEXClass II