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 2551 of 3530
510(k) clearances, page 2551 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K900737Piston Irrigation TrayOrion Life Systems, Inc.EYNClass II
K900708Modified Accufluor Vancomycin Reagent & CalibratorInnotron of Oregon, Inc.LEHClass II
K900689Modified Adac Nuclear Medicine Gamma CameraPhilips North America LLCIYXClass I
K900667Amresco Ldh-L Reagents Products #7710, 7711American Research Products Co.CFJClass II
K900666Amresco Creatinine Reagents Product #7790, 7791American Research Products Co.CGXClass II
K900456Polamedco Nasopaharyngeal AirwayPolamedco, Inc.BTQClass I
K900281Series 3001 IabpBoston Scientific CorporationDSPClass II
K900275Osseodent Dental Attachment, Igloo MagnetCollagen Corp.DZEClass II
K900271Model Ob-500 Fetal Growth Analysis & Option OblinkDigisonics, IncHEMClass II
K896786Zonarex Final Impression CompoundCraft Dental Laboratory, Inc.ELWClass II
K896785Zonarex Final Impression Compound, Operatory Heat/Craft Dental Laboratory, Inc.ELWClass II
K896752Latex Examination GlovesAquatic Import & Export Corp.LYYClass I
K896540Accuspec Thyroid Uptake System SoftwareNuclear Data SystemsIZDClass I
K895635Myosystem 1000 ElectromyographNoraxon USA, Inc.HCCClass II
K894401Balloon Thermodilution CathetersWorldwide Medical Corp.DQOClass II
K893780Ohmeda Excel MRI Compatible Anesthesia SystemGE HealthcareBSZClass II
K885159Mensor MagnaskirtMerrill C. Mensor, Jr., D.D.S.DZEClass II
K901569Bte Hearing Aid, Unitron Models Us80pp and Us80pplUnitron Industries, Inc.ESDClass I
K901556Audiotone Model Ffi Ite Hearing AidMiracle-Ear, Inc.ESDClass I
K901505Arthroscopic Electrosurgical ProbeSmith & Nephew Dyonics, Inc.HRXClass II
K901213Latex Examination GlovesUnited Orient, Inc.LYYClass I
K900965Gs-4550 Trocar Only, 11MmSolos Endoscopy, Inc.FBMClass I
K900964Cannula and Trocar, 11MmSolos Endoscopy, Inc.FBMClass I
K900963Gs-4350 Trocar Only, 5.5MmSolos Endoscopy, Inc.FBMClass I
K900962Gs-4300 Cannula and Trocar, 5.5MmSolos Endoscopy, Inc.FBMClass I
K900961Gs-4100 Reducer Sleeve, 5Mm to 3MmSolos Endoscopy, Inc.FBMClass I
K900960Gs-1500 Claw Forcep, 10MmSolos Endoscopy, Inc.GENClass I
K900959Gs-1400 Toothed Dissecting Forcep, 5Mm, InsulatedSolos Endoscopy, Inc.GEJClass I
K900958Gs-1300 Atraumatic Grasping Forcep, Curved, 10MmSolos Endoscopy, Inc.GEJClass I
K900957Gs-2100 Hook Suture Scissor, 5MmSolos Endoscopy, Inc.LRWClass I
K900956Gs-7100 Cholangiogram Clamp, 5MmSolos Endoscopy, Inc.GDJClass I
K900955Gs-4000 Reducer Sleeve, 11Mm to 5MmSolos Endoscopy, Inc.FBMClass I
K900954Gs-5200 Hook Suction/coagulator, 5MmSolos Endoscopy, Inc.GEIClass II
K900953Gs-5000 Spatula Suction/coagulator, 5MmSolos Endoscopy, Inc.GEIClass II
K900952Gs-1200 Grasping/extracting Forcep, 10MmSolos Endoscopy, Inc.GENClass I
K900951Gs-7000 Clip-Applying Forcep, 10Mm, Medium ClipSolos Endoscopy, Inc.GENClass I
K900950Gs-2000 Micro Scissor, Curved Left, 5MmSolos Endoscopy, Inc.LRWClass I
K900949Gs-1100 Micro Dissecting Forcep, 5Mm, InsulatedSolos Endoscopy, Inc.GEIClass II
K900948Gs-1002 Grasping Forcep, 5Mm with RatchetSolos Endoscopy, Inc.GENClass I
K900947Gs-1000 Grasping Forcep, 5Mm, InsulatedSolos Endoscopy, Inc.GEIClass II
K900839The Carolina RockerArtec Environmental Monitoring DivisionKNNClass I
K900709Air Flow SiiE.M.S. - Electro Medical Systems SAELCClass II
K900585Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc.LHIClass II
K900584Alta Lag Screw and Compression ScrewHowmedica Corp.KTTClass II
K900438Mc2p Acetabular ComponentOsteonics Corp.JDIClass II
K900327Imx Hcg (List #03A63)Abbott MedicalJHIClass II
K900257Muller Type Acetabular CupLima Intl. Corp.JDIClass II
K897178Dynatron 360 Range of Motion Testing DeviceDynatronics Corp.KQXClass I
K897024Model Audina Ite Heating AidAudina Hearing Instrument, IncESDClass I
K896862Model 263 Spectrascan(tm) Holter Analysis SystemDel Mar AvionicsDSIClass II