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 2053 of 3531
510(k) clearances, page 2053 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K952973The Tulip Mono-Polar Cautery SpatulaThe Tulip Mfg. Co.GEIClass II
K943244DeuceApt Technology, Inc.IQAClass II
K953962ForcepsBiopsys Medical, Inc.GENClass I
K953923Uresil Introducing NeedleUresil, LLCKNWClass II
K953880Biopsy NeedleBiopsys Medical, Inc.KNWClass II
K953831N 800 HFNucletron-Oldelft Corp.IZOClass I
K953498Opticlone Igg1 Fitc/igg1 Pe Isotypic ControlIMMUNOTECH s.r.o.GKZClass II
K953496Royal Shield Non-Sterile Powder-Free Hypoallergenic Latex Examination GlovesShield Gloves Manufacturer (M) Sdn BhdLYYClass I
K953375Ng SecureM.C. Johnson Co., Inc.KNTClass II
K953369Stainless Steel Varifix System 5.0Mm Diameter Anchor ScrewAdvanced Spine Fixation Systems, Inc.MNHClass II
K953353Urovision JanusLife-Tech Intl., Inc.FENClass II
K953342Tmr48Pride Health Care, Inc.INOClass II
K953331Combination KitSteri-Oss, Inc.DZEClass II
K953168Ultracid F Disinfecting SolutionUltradent Products Inc.LBHClass II
K953167Ultracid Disinfecting SoloutionUltradent Products Inc.LBHClass II
K953131Exusorb Sterile AbsorbentO.R. Resources, Inc.KMFClass I
K953123Quik-StitchCoral Medical, Inc.GCJClass II
K953070Woundfoam 4 X 4Trinity Laboratories, Inc.KMFClass I
K953025Slt 28Mm Xxl Femoral HeadWrightmedicaltechnologyincJDIClass II
K953018Uni-SiteTtl MedicalMGPUnclassified
K953017Low Profile Titanium Model Catalog #1003Therex Corp.LJTClass II
K952930Dentray II Plus Tray AdhesiveConfi-Dental Products Co.ELWClass II
K952873Medix Biotech Strep a Antigen Detection Test (Modification)Medix Biotech, Inc.GTZClass I
K952855Pc-LockMidwest Orthodontic Mfg.DYHClass II
K952810Dosi-Flow, Models 20 & 30Leventon, S.A.FPAClass II
K952730Hoffmann II External Fixation SystemHowmedica Corp.JECClass II
K952639Disposable Toothed Grasping ForcepNeuro Navigational Corp.HRXClass II
K952630Disposable Biopsy ForcepNeuro Navigational Corp.HRXClass II
K952629Nexflex Total Hip SystemNexmed, Inc.JDIClass II
K952615Wako Autokit Apo A1FUJIFILM Healthcare Americas CorporationJHNClass I
K952271Genesis Constrained System (Gcs)Smith & Nephew Richards, Inc.JWHClass II
K952252Adp Reagent, ModifiedHelena Laboratories, Corp.GHRClass II
K952251Immulite Hcg High Level Control ModuleSiemens Healthcare Diagnostics Inc.JJXClass I
K951990Laparoscope, Rod-Lens Viewing and Operating EndoscopeSchoelly Technologies, Inc.GCJClass II
K951725Osteonics Spinal SystemOsteonics Corp.MNHClass II
K951595Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc.CGXClass II
K951565Innovasive Devices Rotator Cuff FastenerInnovasive Devices, Inc.MBIClass II
K951256Detachable Platinum Coil (Guglielmi Detachable Coil, Gdc)Target TherapeuticsHCGClass II
K950960Reddy IlluminatorLuxtec Corp.FFSClass II
K945747Gambro Lundia 94-600 DialyzerCobe Renal Care, Inc.KDIClass II
K945746Gambro Lundia 94-500 DialyzerCobe Renal Care, Inc.FJIClass II
K944553Pressure Sensing Scope Sheath SystemLinvatec CorporationHRXClass II
K941801AnalgraphDiversatek Healthcare IncKLAClass II
K940472Coxsackievirus B5 Monoclonal AntibodyChemicon Intl., Inc.GNMClass I
K940471Coxsackievirus B Blend Monoclonal AntibodiesChemicon Intl., Inc.GNMClass I
K940363Enterovirus 70 Monclonal AntibodyLight DiagnosticsGOEClass I
K940018Poliovirus 1 Monoclonal AntibodyLight DiagnosticsGOEClass I
K936254Cocksackievirus B6 Monoclonal AntibodyLight DiagnosticsGNMClass I
K936253Coxsackievirus B4 Monoclonal AntibodyLight DiagnosticsGNMClass I
K936252Coxsackievirus B@ Monoclonal AntibodyLight DiagnosticsGNMClass I