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 1831 of 3531
510(k) clearances, page 1831 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K971314Dcat Embolectomy Catheter SystemBoston Scientific CorporationDXEClass II
K963965Cts Midcab StitcherCardiothoracic Systems, Inc.GEIClass II
K980677Nitrile Exam Glove, Powder FreeNingbo Yujiang Plastic & Rubber Co., Ltd.LZAClass I
K980582Multi-Link Cable and Lead Wire SystemsMarquette Medical Systems, Inc.DSAClass II
K980442Crystal and Crystal-Seal Implants SystemCrystal Medical TechnologyDZEClass II
K980439Replace Cylindrical ImplantsSteri-Oss, Inc.DZEClass II
K980430Radionics Disposable RF Cannulae (Sc-C, Rfk-Db, Rfk-Ds)Radionics, Inc.GXIClass II
K980331Immunosuppressant (Whole Blood) Control, Level 1 250-1, Immunosuppressant (Whole Bloos) Control, Level 2, 250-2, Immun\sMore Diagnostics Inc.DIFClass I
K980201Dio-Light Laser SystemNidek, Inc.GEXClass II
K980103Acumed Suture AnchorAcu Med, Inc.MBIClass II
K974911External FixatorAvanta Orthopaedics, Inc.JDWClass II
K974865CsrParkell, Inc.EBIClass II
K974807Osteo Austin Moore Endoprosthesis SystemOsteonics Corp.KWLClass II
K974206Synthes Cranial Spring Clip (Csc)Synthes (USA) Products LLCGWOClass II
K973854Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc.KWQClass II
K972241Zoll ReviverZOLL Medical CorporationMKJClass III
K971740Amplaid Mk12AmplifonGWFClass II
K971612Osmo/pca Pillow Wound DressingProcyte Corp.KMFClass I
K980618Lovytex Sdn Bhd Powder-Free Latex Examination GlovesLovytex Sdn BhdLYYClass I
K980572Powder-Free Latex Examination Gloves with Protein Labeling Claim (Green)Hartalega Sdn BhdLYYClass I
K980511Nitrile Examination Gloves - Powder FreeInflux Pacific Sdn. Bhd.LZAClass I
K980421Omni Touch Nitrile Examination Glove, PowderedOmnigrace (Thailand), Ltd.LZAClass I
K980419Omni Flex Nitrile Examination Glove, Powder-FreeOmnigrace (Thailand), Ltd.LZAClass I
K980285Powderfree Blue Nitrile Examination GlovesBesglove Medicare Sdn. Bhd.LZAClass I
K980280Powdered Nitrile Examination Gloves (Blue Colour)Besglove Medicare Sdn. Bhd.LZAClass I
K980275Powderfree Blue Nitrile Examination Gloves (Polymer Coated)Besglove Medicare Sdn. Bhd.LZAClass I
K980249Accusign Tca, Biosign Tca, Staus Ds TcaPrinceton BioMeditech Corp.LFGClass II
K980215Latex Examination GlovesP.T. Wantong IndustryLYYClass I
K980194Powderfree Latex Examination GlovesBesglove Medicare Sdn. Bhd.LYYClass I
K980167Powderfree Latex Examination GlovesBesglove Medicare Sdn. Bhd.LYYClass I
K980163Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume CoveringBoston Scientific CorporationJCTClass II
K980071Supergloves Low Protein Powder Free Latex Examination GlovesSupermax Latex Products Sdn. Bhd.LYYClass I
K980003M500-100 Sharps ContainerImagination Medical, Inc.FMIClass II
K974907Nitrile Pre-Powdered Examination GlovesSmart Glove Corp. Sdn BhdLZAClass I
K974903Gas Module II, Model 0998-00-0143Datascope Corp.CBSClass II
K974870Latex Examination Glove Powder FreeSmart Glove Corp. Sdn BhdLYYClass I
K974817Drg Mf Titaniun Alloy Bone Screw 1.0Mm, 1.2Mm, 1.3Mm, 1.5Mm, 1.7Mm, 2.0Mm, 2.4MmDoctor'S Research Group, Inc.DZLClass II
K974773Hi-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Standard Guide Wire with Hydrocoat HydrophilicBoston Scientific CorporationDQXClass II
K974749Synergy Closed Variable Locking Screw (Vls), Part of the Cross Medical-Synergy Anterior and Posterior Spinal SystemsCross Medical Products, Inc.MNHClass II
K974720Howmedica(r) Fully Threaded ScrewsHowmedica Corp.HSBClass II
K974706Aesculap Abc Cervical Plating SystemAesculap IncKWQClass II
K974672Msi Surgical DrapesMedical Specialty Innovations, Inc. (Msi)KKXClass II
K974670Athena 1:1 Contra Angle, Athena 4:1 Contra Angle, Athena 16:1 Contra Angle, Athena 64:1 Contra Angle, Athena 16-: ContreAthena Technology, Inc.EFBClass I
K974653Silicone Elastomer SheetingSpecialty Surgical Products, Inc.MIBClass II
K974642Combicath CatheterPlastimed Laboratoire PharmaceutiqueEOQClass II
K974640Coaxial Dilator SetBoston Scientific CorporationDREClass II
K974557SmarttexSmart Glove Corp. Sdn BhdLYYClass I
K974009Ps-Unit Cassette/serum and Urine Combo HcgInternational Newtech Development, Inc.JHIClass II
K973664Latex Exam Glove, Powder-Free W/protein & Hypoallergenic LabelingEvergrade Healthcare Products Sdn BhdLYYClass I
K973628Vitalab Flexor/vitalab Selectra 2/Vitalab VivaVitalScientificJJFClass I