510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3260 of 3528
510(k) clearances, page 3260 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K813032Zikon 100 Digital X-Ray SystemKontron Instruments, Inc.JABClass II
K813016Zee Traction SplintZee Medical Products Co., Inc.HSTClass I
K813005Kodak Cinefluorographic Film So-274Eastman Kodak CompanyIWZClass I
K812982Blom-Singer Voice ProsthesisBivona Medical TechnologiesEWLClass II
K812979Vitamin B12/folate Dual Radioassay KitsAmersham Corp.CGNClass II
K812966400T Ect SoftwareGeneral Electric Co.JWMClass II
K812963Ibis IICgr Medical Corp.JAAClass II
K8129293.5 Mhz Biopsy TransducerGeneral Electric Co.ITXClass II
K812915Mx 125General Electric Co.ITYClass I
K812913Omega II Angiographic TableGeneral Electric Co.IZIClass II
K812908Electro-GoniometerChattanooga Group, Inc.KQXClass I
K812885Dulbecco Minimum Essential Med No GlutamDutchland Laboratories, Inc.KITClass I
K812880Ohio Non-Reusable Tracheal Tube MajillAirco/Ohio Medical ProductsBTRClass II
K812879Ohio Non-Reusable Tracheal Tube MurphyAirco/Ohio Medical ProductsBTRClass II
K812864Silastic Voice ProsthesisDow Corning Corp. Healthcare Industries MaterialsEWLClass II
K812791Portable Medical TableRichard D. SpradlinKXJClass II
K812628Aca Fibrinogen CalibratorE.I. Dupont de Nemours & Co., Inc.GFXClass II
K812626Aca Antithrombin III Plasminogen CalibE.I. Dupont de Nemours & Co., Inc.JBQClass II
K812391NeurospongesWinn Hirsch & Assoc.GDYClass I
K812390Neurosponge PaddieWinn Hirsch & Assoc.GDYClass I
K812248Cooley 2 Vascular Prosthesis StraightMeadox Medicals, Div. Boston Scientific Corp.DSYClass II
K811114Model P-8 ProfessionalBloomex International, Inc.
K813133Keymed Key LightKeymed, Inc.HETClass II
K813104Power Drive WheelcrIntl. Medical Equipment Corp.ITIClass II
K813098TENS DeviceStaodynamics, Inc.
K813094Acetabular Cement CompressorRichard'S Medical Equip., Inc.
K813093Richards Acetabular BrushRichard'S Medical Equip., Inc.HTRClass I
K813089Cement RingZimmer GmbHJDIClass II
K813085Hepafix Biopsy Needle SetBurron Medical Products, Inc.KNWClass II
K813070PeriografSterling Drug, Inc.LYCClass II
K813027Sterile Irrigating Syringes, Kits,trayWelcon, Inc.KYZClass I
K812962Boundary Surgical DrapeThe Buckeye Cellulose Corp.KKXClass II
K812876Surgical PawsM-W Laboratories, Inc.GDZClass I
K812875Surgical LoopsM-W Laboratories, Inc.GADClass I
K812819Ethicon* Surgical Sutures W/compress BolEthicon, IncKGSClass I
K812603TanaramaMarketing Consultants of AmericaGGGClass II
K812396Arthro-Prep RestNorthwest Surgical Concepts, Inc.BWNClass I
K812395Arthro-Prep Rest W/standNorthwest Surgical Concepts, Inc.BWNClass I
K812364Port. Toothbrush Kit W/4 G. ToothpasteJdm CommoditiesEFWClass I
K812363Disp. Toothbrush W/toothpaste AttachedJdm CommoditiesEFWClass I
K812362Disp. Toothbrush W/3 G. Tube of ToothpstJdm CommoditiesEFWClass I
K812361Portable Toothbrush Kit (No Sample)Jdm CommoditiesEFWClass I
K812018X-Ray Detectable ThreadIsramed, Inc.GDYClass I
K812017X-Ray Detectable BandIsramed, Inc.GDYClass I
K811842Imager 2000 Real Time SystemSiemens Gammasonics, Inc.IYOClass II
K811101HydroxylapatiteCarbomedics, Inc.LYCClass II
K813080Wound Drainage Management SystemsHowmedica Corp.EXBClass I
K813026Guide WireInmed Corp.OCYClass II
K812889Estilux PosteriorKulzer GmbHEBFClass II
K812887Robinson Catheters Non-SterileAbco Dealers, Inc.KODClass II