510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3036 of 3529
510(k) clearances, page 3036 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K842324PerfourmCutter Laboratories, Inc.ELWClass II
K844177Cosgrove Mitral Valve RetractorKapp Surgical GmbHGADClass I
K844005Arm-a-Vial Lv Heater-Breathing SysArmour Pharmaceutical Co.BZEClass II
K844002Hu-Friedy Ims Cassette SystemHU-Friedy Mfg. Co. LLCFSMClass I
K844001Lance Blades & ScalpelsPerry, Div.GESClass I
K843966Argon/krypton Laser Photocoagulator SysAmerican Medical OpticsHQBClass II
K843902Solar-Gold UV-a by EosEos-Werke, Gunther GmbHFTCClass II
K843857Transferscreen IIErich Jaeger, Inc.
K843808Dual Chennel Brain Activity MonitorDatex Division Instrumentarium Corp.OLTClass II
K843634Asc 4080 SystemAtlantis Scientific Corp.IKEClass I
K843288Ketronic Medax - NKetronic, Inc.IYXClass I
K843235StenoscopCgr Medical Corp.JAAClass II
K843140Isolate Adhesive Bandage for Dry WoundChesebrough-Pond'S U.S.A. Co.NADClass I
K843139Isolate Adhesive Bandage for Moist WoundChesebrough-Pond'S U.S.A. Co.NADClass I
K842967Aquaphor R GauzeBeiersdorf, Inc.FROUnclassified
K842893Dorr Hip Prosthesis, Acetabular ComponCarbomedics, Inc.JDLClass III
K842690Synectics Ph & Pressure Esophageal MonitSynectics ABFFTClass I
K842644Tpn/hyperalimentation TrayDeRoyal Industries, Inc.FRGClass II
K842217Idas Digital Fluoroscopic Imagins SysMicro Consultants, Inc.JAAClass II
K841896Ez Eye Drop AidBuckman Co., Inc.
K841860CO2 Surgical Laser System Xml-10Xanar, Inc.EWGClass II
K841246Portable Nursing Unit TerminalNcr Corp.DXNClass II
K840815Luer Locking Adapter(material Change)Quinton, Inc.FOZClass II
K834343Comfeel PowderMEDLINE INDUSTRIES, LP - NorthfieldKOZClass I
K844231Sceptor Beta-Lactam Plus Mic PanelBD Becton Dickinson Vacutainer Systems PreanalyticLTWClass II
K844199Elastic Style Impervious Orthopedic StockinetKleen Test Products CorporationKKXClass II
K844152HemstatsI M, Inc.HRQClass I
K844151Sets and TraysI M, Inc.
K843960Deodorant Maxithins Body-Shaped Panty ShieldsTambrands Inc.HHLClass II
K843959Deodorant Regular Maxithins Body-Shaped Maxi PadsTambrands Inc.HHLClass II
K843958Deodorant Super Maxithins Body-Shaped Maxi PadsTambrands Inc.HHLClass II
K843788Custom Burn Dressing KitHermitage Hospital Products, Inc.KGNUnclassified
K843691Portable Oxygen UnitB & F Medical Products, Inc.CAWClass II
K843543The Bibicure Sys Dermepil Natural HairLes Entreprises Bibi, Inc.
K843300Skin-LiteGuardian ChemicalKMFClass I
K842718HydroxyapatiteDepuy, Inc.LYCClass II
K841781Model 305Aa Portable LaserLaser Spectrum, Inc.GEXClass II
K840438Comfeel Ulcus SheetMEDLINE INDUSTRIES, LP - NorthfieldFROUnclassified
K840362Comfeel PasteMEDLINE INDUSTRIES, LP - Northfield
K843965Argon Laser Photocoagulator SysAmerican Medical OpticsHQFClass II
K843678Creat Brand Skin ExpanderAesthetech Corp.LCJUnclassified
K843345Agl400 Argon Laser System-Krl500 KryptonMira, Inc.
K844072Dermizip Skin Closure DeviceKells Medical, Inc.
K844039Aztech Industries Suntanning Bed Az100Aztech Industries, Inc.FTCClass II
K843985Suspension 7Cgr Medical Corp.
K843925Gill's Irrigator/aspirator NeedleConcept, Inc.GAAClass I
K843906Snyder Hemovac Wound Drainage DevicesSnyder Laboratories, Inc.GBSClass I
K843882Trends LancetOrange Medical Instruments, Inc.KMKClass I
K843525Suture TrayPro-Lab, Inc.
K843399Surgeons Choice Pi Vascular StaplingSurgeons Choice, Inc.GDWClass II