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 2613 of 3530
510(k) clearances, page 2613 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K890472Ath Ceramic Uhmwpe Total Hip SystemKinamed IncLZOClass II
K890115Ambi-Dex (Latex Examination Gloves)Globe Safety Products, Inc.LYYClass I
K885069Zirconia Ceramic Head (Yitria Stabilized)Richards Medical Co., Inc.LZOClass II
K883717Bio-VentCore-Vent Corp.DZEClass II
K883619Medicated Covering Coated W/1.0% Hydro Adhes. GelMinnetonka, Inc.SEKUnclassified
K883566Medicated Covering Coated W/.5% Hydro Adhesive GelMinnetonka, Inc.SEKUnclassified
K8948508053 Two Stage Type a-B Nitrous Oxide Therapy CyliModern Engineering Co., Inc.CANClass I
K894776Sensititre Indole ReagentRadiometer America, IncJSSClass I
K894710Dpc-Robostat(tm)Siemens Healthcare Diagnostics Inc.JQWClass I
K894687Dynatech Mr 5000, Catalog #011-976-0600Dynatech Laboratories, Inc.JJQClass I
K894508Magnesium Test Item Number: 65419Em Diagnostic Systems, Inc.JGJClass I
K894378Urea Nitrogen Test (Bun) Item #65408Em Diagnostic Systems, Inc.CDQClass II
K894366Rep Hdl-8 Kit, No. 3188, Rep Hdl-16 Kit, No. 3187Helena Laboratories, Corp.LBTClass I
K894288Phosphorus Test Item Number 65416Em Diagnostic Systems, Inc.CEDClass I
K894254Hypafix Dressing Retention SheetSmith & Nephew United, Inc.NADClass I
K894181Positive and Negative Hcg Urine ControlsArmkel, LLCJJXClass I
K894081Rocho Isomune - LdRoche Diagnostic Systems, Inc.CFEClass II
K894057Quikread Whole Blood Hdl-Cholesterol Test KitPhotec Diagnostics, Inc.LBSClass I
K894032Evac-TubeSharn, Inc.CAOClass II
K894023Patient Examination Gloves (Vinyl)Baxter Healthcare CorporationLYZClass I
K894022Patient Examination Gloves (Latex)Baxter Healthcare CorporationLYYClass I
K893915Emds Total Protein (Tp), Item Number 65420Em Diagnostic Systems, Inc.CEKClass II
K893838Modified Model 570 Clinical Chemistry AnalyzerCiba Corning Diagnostics Corp.JQPClass I
K893691Emds Creatine Kinase Item Nimber 65411Diagnostic SystemsCGSClass II
K893450Latex Examination GlovesKen FA Latex Products Corp.LYYClass I
K892973Latex Non-Sterile Patient Examination GlovesPolikon Trading Co.LYYClass I
K892963Patient Examination GlovesMao Gang Industrial Co.LYYClass I
K892646Biochem 8100 Anesthetic Agent MonitorBiochem International, Inc.CBQClass II
K891965Sofcare Patient Examination Gloves (Latex)P. T. Tata Rubberindo IndustriesLYYClass I
K891793Micromed Latex Examination GlovesSiamland, Inc.LYYClass I
K891785Bion Ebv-G (Vca) Test SystemBion Ent., Ltd.JRYClass I
K891731Patient Examination Gloves (Latex)Southern Medical Products, Inc.LYYClass I
K891730Patient Examination Gloves (Latex)Athena Mfg., Inc.LYYClass I
K891724Patient Examination Gloves (Latex)United Lion Rubber Industries Sdn. Bhd.LYYClass I
K891674Neonatal Environmental Monitor, Model 275Preemicare Corp.CCLClass II
K891323Li Wah Latex Examination GlovesLi Wah-Hong Kong, Inc.LYYClass I
K890905Disposable Non Sterile Latex Exam GlovesHarvest Intl. of America, Inc.LYYClass I
K894929Staple Fixation SystemConcept, Inc.JDRClass II
K894830Cypress Cannulated Bone ScrewCypress Medical Mfg., Inc.HWCClass II
K894544Biotrol Rub-E.i.a. Test GBiotrol, USA, Inc.LFXClass II
K894235Eb Vca Stat M Test KitWhittaker Bioproducts, Inc.LSEClass I
K893455The Handscan SystemDigital Body Systems, Inc.KQXClass I
K893085Patient Examination GlovesJiangsu Medicines & Health Products Import & ExporLYYClass I
K891504Patient Examination Glove (Latex)Lon Tai Chemical Industrial Co., Ltd.LYYClass I
K894789Dmi 250 Series Power Surgery TableM.D. Intl., Inc.JEAClass I
K894773Latex Patient Examination GlovesTransrich Industries Sdn. Bhd.LYYClass I
K894324Latex Examination GlovesM/S Overseas Latex Pvt., Ltd.LYYClass I
K894212Phyne-Touch-SterileMedical Resources, Ltd.LYYClass I
K894164Models 4000,4900,6000,8000,8900 Nd Yag 1700NdHeraeus Lasersonics, Inc.GEXClass II
K894125Patient Examination GlovesYaw Chang Enterprises Co., Ltd.LYYClass I