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 1205 of 3531
510(k) clearances, page 1205 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K070836Exiclip Excs-MClevex, Inc.MJGClass I
K070247Giraffe and Panda Bag and Mask Resuscitation SystemGE HealthcareBTMClass II
K070210Giraffe and Panda T- Piece Resuscitation SystemGE HealthcareBTLClass II
K070082Xy Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,IncMQPClass II
K070022Mistral - One Stage Screw-Type Dental Implant, Model Mf9MIS Implants Technologies Ltd.DZEClass II
K062104Talking TrachEngineered Medical Systems, LLCBTOClass II
K061815Cook Celect Vena Cava FilterWilliam Cook Europe ApSDTKClass II
K071007Heartway Lightweight Power Mobility Scooter, S33Heartway Medical Products Co., Ltd.INIClass II
K070943B-Scan PlusAccutome Ultrasound, Inc.IYOClass II
K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc.KWQClass II
K070710Accutrans Disposable Pressure Monitoring SystemBiosensors International-USADRSClass II
K070483Leone Monoimplant for O-Ring OverdentureLeone S.p.A.DZEClass II
K070316Interplate Vbr SystemRSB Spine LLC.MQPClass II
K070254Horizon SeMennen Medical, Inc.DQKClass II
K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc.HPZClass II
K063059Sorbact Wound DressingAbigo Medical ABFROUnclassified
K061756Textured Powder Free Nitrile Exam Gloves with SapShen Wei (USA), Inc.LZAClass I
K070676Korebalance (Kinesthetic Ability Trainer)Sportkat, LLCLXVUnclassified
K070506Sms Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc.JJXClass I
K070181Sintea Biotech Dsc/alf Spinal System, Dsc.xx.t5.xx, Alf.xx.t5.xxSintea Biotech, Inc.MQPClass II
K070168N95 Respirator, Models N9504c, N9504cs and N9514cAearo CompanyMSHClass II
K070091Coaxial Bone and Vertebral Body Biopsy Needle Model# Jbc1213, Jbc1208Medtronic, Inc.KNWClass II
K063468The Fugo Blade for DentistryMedisurg, Ltd.EKZClass II
K063346Pro Osteon 500REbi, LLCMQVClass II
K070907Interson Usb Ultrasound Probe SystemRegulatory Management ServicesIYOClass II
K070467Health MaskPolar Wrap, LLCOBNClass II
K070466Revolix Duo Laser SystemAllmed Systems, Inc.GEXClass II
K070462Xpert MrsaCepheidNQXClass II
K070290Spi Vectodrill Ceramic DrillsThommen Medical AGNDPClass I
K070243Sutralene Polypropylene SuturesVisionary Medical Supplies, Inc.GAWClass II
K070224Ultrapro PlugEthicon, IncFTLClass II
K070172Amplicor Ct/ng Test for Neisseria GonorrhoeaeRoche Diagnostics GmbHLSLClass II
K063842Cyrtina SystemOratio B.V.EIHClass II
K063354Linde Integrated Valve (Liv)Linde Gas TherapeuticsECXClass I
K063306Ace Hemoglobin A1c Reagent, Model Aci-21, Hemoglobin A1c Calibrators, Model S2-72, Hemoglobin A1c Controls, Model C2-72Alfa WassermannLCPClass II
K062453Kingly Star Powered Muscle Stimulator, Model Ks-138Kingly Star Intl. Technology Co., Ltd.IPFClass II
K060915Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and AppliersKirwan Surgical Products, LLCHCHClass II
K070950Lift Chair, Model C5Pride Mobility Products CorpINOClass II
K070858Express SeriesMedical Graphics Corp.BZLClass II
K070583Nano CompositeCosmedent, Inc.EBFClass II
K070335Simplex Cervical Fixation SystemPisharodi Surgicals, Inc.KWQClass II
K070278Polarcup Dual Mobility SystemPlus OrthopedicsLPHClass II
K070227Opus Magnum Pi Knotless Fixation DeviceArthroCare CorporationMBIClass II
K070174Amplicor Ct/ng Test for Chlamydia Trachomatis; Roche Scripts for Ct/ng Test AccessoryRoche Diagnostics GmbHMKZClass I
K070125Colleague Guardian Configuration Tool; Colleague Dl2 Event History Download Software ApplicationBaxter Healthcare CorporationFRNClass II
K063790The Synthes Matrixmandible Plate and Screw SystemSynthes (USA) Products LLCJEYClass II
K063784Dye Management SystemAbbott MedicalDQOClass II
K063359InquIsto Technologies, Inc.MQVClass II
K063329Abbott Architect Havab-MAbbott MedicalLOLClass II
K063271Aquacel Hydrofiber Dressing and Aquacel Ag with Hydrofiber Silver Impregnated Antimicrobial DressingConvatec, A Division of E.R. Squibb & SonsFROUnclassified