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 2057 of 3531
510(k) clearances, page 2057 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K944713W&h Micro Air Motor Lt25A-dec, Inc.EFBClass I
K944492Dialyzer Reprocessing SystemG.E.M. Water SystemsLIFClass II
K944393Stryker Steri-Shield Surgical ApparelStryker Corp.FYAClass II
K944305Friedrich Electronic Air CleanerFriedrich Air Conditioning Co., Inc.FRFClass II
K930665Century Bathing SystemArjo-Century, Inc.ILJClass II
K953764Lmt Bone AnchorLi Medical Technologies, Inc.JDRClass II
K953677Lighted Flexguide (Modification)Scientific Sales Intl., Inc.BSRClass I
K953620Warm N Wet Hmef W/luer AdapterHospitak, Inc.BYDClass I
K953619Warm N Wet Hme W/luer AdapterHospitak, Inc.BYDClass I
K953544Humid-Vent 2 Light/humid-Vent 2 Port LightGibeck, Inc.BYDClass I
K953540EeeEdentec Corp.BYDClass I
K953491Humid-Vent 1 Port/humid-Vent 1 Port AngleGibeck, Inc.BYDClass I
K953344Degubond UltraDegussa AGEJTClass II
K953301Dentastic One-StepPulpdent CorporationEMAClass II
K953272Pulpdent Dentastic IIPulpdent CorporationEMAClass II
K953217Pulpdent TouchdownPulpdent CorporationDYHClass II
K953109Hand Extractor HectorKarl Storz Endoscopy-America, Inc.HIHClass II
K952670CupralloyWykle Research, Inc.EJJClass II
K952626Mapwire J-Tip Sensor GuidewireNavion Biomedical Corp.LJSClass II
K952607Auraflex Tpo-AbbioMerieux, Inc.JNLClass II
K952508Flow-Therme, Wisap #7642Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbHHETClass II
K952480Orims Digital Angiography SystemMidwest Ophthalmic Instruments, Inc.HKIClass II
K952327Smartsat Pulse Oximetry AnalyzerClinical Dynamics Corp.DQAClass II
K952291Gammacell 3000 ElanNordion International, Inc.MOTUnclassified
K951510Ace Bone Screw Tacking KitAce Surgical Supply Co., Inc.DZLClass II
K951320Auraflex Tg-Ab and Tpo-AbbioMerieux, Inc.JNLClass II
K951232Expanded Range of Suture Sizes Ogden Anchors: 7.4Mm and 5.5MmAmerican Medical Electronics, Inc.HWCClass II
K950955Paragon Posterior Spinal SystemSofamor Danek USA,Inc.MNHClass II
K950824Stryker Drop Applicator, Kits, Spray Applicator Kit, TipsStryker Corp.FMFClass II
K950742Cyto-Stat/coulter Clone Cd3-Ecd/t4-Rd1/t8-Fitc Monoclonal Antiboey ReagentCoulter Corp.GKZClass II
K950194Tampon, UntreatedHygieia Healthcare, Ltd.HEBClass II
K944714W&h Corsair ScalerA-dec, Inc.EFBClass I
K944712W&h Micro Motor E25 (without Light)A-dec, Inc.EFBClass I
K944711W&h Air Motor A25A-dec, Inc.EFBClass I
K943725Universal Spinal Rod and Screw Fixation SystemSynthes GmbHKWQClass II
K943531Oxylog 2000Drager, Inc.CBKClass II
K942889Sb AnchorOrthopaedic Biosystems, Ltd.JDRClass II
K941308Newport Electronic ManometerNewport Medical Instruments, Inc.CBKClass II
K941118Head Immobilization ApparatusNorthwest Medical Physics CenterIYEClass II
K953524Ultra-BlendUltradent Products Inc.EJKClass II
K953520Olympus Rheumatoid Factor Immunoturbidimetric ReagentOLYMPUS Corporation of the AmericasDHRClass II
K953160Opus T3Behring Diagnostics, Inc.CDPClass II
K953097Opus T4 ControlsBehring Diagnostics, Inc.JJXClass I
K953094Axsym AcetaminophenAbbott MedicalLDPClass II
K953016Axsym Theophylline IIAbbott MedicalLGSClass II
K952877Csf Liquid Cerebrospinal Fluid ControlMedical Analysis Systems, Inc.JJYClass I
K952839Boehringer Mannheim Ethyl Alcohol AssayBoehringer Mannheim Corp.DMLClass II
K952768Alkphase-B Assay KitMetra Biosystems, Inc.CINClass II
K952583AquisenAquintel, Inc.LJHClass II
K952531Quest Vein Graft Perfusion SetQuest Medical, IncDTLClass II