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 2655 of 3530
510(k) clearances, page 2655 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K891212Aprons, Scrubs Slacks & Tops, Patient DrapePro-Safe Professional Linens, Inc.FXOClass I
K891211Surgical Gown #2001Pro-Safe Professional Linens, Inc.FYAClass II
K890853Aqua-Pad for Moist or Dry Heat TherapyAtiILOClass II
K890852Aqua-Blanket Hyper/hypohermia BlanketAtiILOClass II
K890831Emit Convenience Pack: Thyroxine AssaySyva Co.KLIClass II
K890666Model 3031; Cervical Spine Surface CoilMedical Advances, Inc.LNHClass II
K890517Transcutaneous O2/co2 MonitorNovametrix Medical Systems, Inc.LKDClass II
K890485Wang Front Loading ApplicatorMick Radio-Nuclear Instruments, Inc.IWJClass I
K890397Redi-Vu Model Rv-386J.D. Technical ServicesLLZClass II
K890173Interspec ApogeeInterspec, Inc.IYOClass II
K885224Ana-5 Autoantibody Profile KitAutoimmunity Diagnostics Corp.LKJClass II
K884937Beehive-64 or Beehive-32, Digital EEG RecordingGrass-Telefactor Product GroupEEGClass I
K884673Apex 215M Mobile Anger CameraElscint, Inc.IYXClass I
K884586Comfortron Dental Anesthesia ApparatusM. D. ProductsLWMUnclassified
K883609Acces. Package for Use W/cardiogen-82 GeneratorSquibb DiagnosticsFRNClass II
K882449Cesium 137 Source, Model Csm-40Cis-Us, Inc.IWIClass II
K882303H&m Anti-Snoring DeviceHays & Meade, Inc.LRKClass II
K881329Fetal Doppler for Ultramark 4 and 8Advanced Technology Laboratories, Inc.HEMClass II
K891884Patient Examination Gloves (Latex)Duflex Products Sdn. Bhd.LYYClass I
K891639Patient Examination Gloves (Latex)Tak Ent., Inc.LYYClass I
K891632Patient Examination Gloves (Latex)Rank Rubber Industries Sdn BhdLYYClass I
K891356Patient Examination Gloves (Vinyl)PM Gloves, Inc.LYZClass I
K891264Patient Examination Gloves (Latex)Safeskin Corp.LYYClass I
K891255Curity Disposable Latex GlovesKendall Healthcare Products Co. Div.Of Tyco HealthLYYClass I
K891112Patient Examination Glove (Latex)MedgloveLYYClass I
K890432Deknatel High Precision Vascular Punch(tm)Deknatel, Inc.DWSClass I
K890100Penn-Pet ScannerUgm Medical Systems, Inc.KPSClass II
K891902Chisels- Freer, Lucas, Alexander, BishopZinnanti Surgical Instruments, Inc.KGDClass II
K891901Gouges, Alexander, Bishop, LucasZinnanti Surgical Instruments, Inc.GDHClass I
K891899Elevators, Various TypesZinnanti Surgical Instruments, Inc.GEGClass I
K891898Skin Hooks, Various TypesZinnanti Surgical Instruments, Inc.GDGClass I
K891896Tissue Forceps, Various TypesZinnanti Surgical Instruments, Inc.GENClass I
K891895Surgical LoupesZinnanti Surgical Instruments, Inc.FSPClass I
K891894Elevators-Cottle,mckenty,goldman,joseph,converseZinnanti Surgical Instruments, Inc.GEGClass I
K891892Rollet RetractorZinnanti Surgical Instruments, Inc.GADClass I
K891889Olivecorona ScissorsZinnanti Surgical Instruments, Inc.LRWClass I
K891888Currettes - Piffard, Wolf, Vidal-ScraperZinnanti Surgical Instruments, Inc.FZSClass I
K891887Osteotomes, Various TypesZinnanti Surgical Instruments, Inc.GFIClass I
K891886Scissors, Various TypesZinnanti Surgical Instruments, Inc.LRWClass I
K891877Patient Examination Gloves (Latex)W.A. Rubbermate Co. C/O Orient Intl. Trading, Inc.LYYClass I
K891868Patient Examination Glove (Latex)Bber Sound Rubber Industrial Co., Ltd.LYYClass I
K891683Titan Gel Ife Free Kappa/lamba Light Chain AntiserHelena Laboratories, Corp.CZNClass II
K891535P-C Palladium Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891534M-75 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891533M-74 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891532M-70 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891531M-50 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891529M-W Silver Palladium Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891528M-65 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891527M-60 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II