510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 294 of 3528
510(k) clearances, page 294 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA IncMAXClass II
K213650ThermPix Thermovisual CameraUSA Therm Inc.LHQClass I
K213557FinexelSNJ Co., Ltd.GEXClass II
K213518CARESCAPE CO2 Microstream parameterMedtronic, Inc.CCKClass II
K213398EMBOLD Fibered Detachable Coil SystemBoston Scientific CorporationKRDClass II
K213296Anprolene SteriTest RRBIAndersen Sterilizers, Inc.FRCClass II
K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201GE Medical Systems Information Technologies, Inc.MHXClass II
K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLCMAXClass II
K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)Signature Orthopaedics Pty LimitedJWHClass II
K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea TechnologiesOWNClass II
K220209Powder Free Nitrile Examination Glove, Non-sterile (Blue)KSG Medicare Sdn BhdLZAClass I
K220158G-EYE SystemSmart Medical Systems Ltd.FDFClass II
K220121Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and BlackAamedix Glove Sdn BhdLZAClass I
K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLCDQYClass II
K213675MP Reconstruction SystemWaldemar Link GmbH & Co. KGLZOClass II
K213437Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsCentral Medicare Sdn BhdLZAClass I
K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLCOURClass II
K212881Intense Pulsed Light (IPL) SystemShenzhen Fansizhe Science and Technology Co., Ltd.OHTClass II
K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.KRAClass II
K220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test ClaimRiverstone Resources Sdn BhdLZAClass I
K212929Nitrile Examination GlovesWatchtower Ppe Supplies, Inc.LZAClass I
K220809Drive Rail SystemOrthopediatrics CorpKTTClass II
K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea InternationalNKBClass II
K220699Prestige Coil SystemBait USA, LLCKRDClass II
K220490ImaCor Zura Handheld ZHH-010IMACOR, IncIYNClass II
K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationLNHClass II
K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TNORAS MRI products GmbHMOSClass II
K213958Bioabsorbable AnchorEmbody, Inc.MAIClass II
K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery IncGAGClass II
K213509Latex Examination Gloves, Powder FreeShandong Intco Medical Products Co LtdLYYClass I
K213063TLX SRAs and TLX Gold AbutmentsStraumann USA, LLCNHAClass II
K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment(guangzhou) Co., Ltd.FIEClass II
K212882SCOUT BX Delivery SystemMerit Medical Systems, Inc.NEUClass II
K212372Fitbit Irregular Rhythm NotificationsFitbit LLCQDBClass II
K212309Non-sterile, Powder-Free Latex Examination GloveSRI Trang Gloves (Thailand) Public Company Limited.LYYClass I
K212274INT ContourCarina Medical LLCMUJClass II
K212017Thermeo SystemPRO3DURE Medical GmbHMQCUnclassified
K210109visor2 systemEemagine Medical Imaging Solutions GmbHHAWClass II
K202389Oxygen ConcentratorFoshan Mic Medical Technology Co., LtdCAWClass II
K220287Invisalign SystemAlign Technology, Inc.NXCClass II
K212278ElectrocardiographEdan Instruments, Inc.DPSClass II
K212203Dong Hai Xiang Surgical MaskTaizhou Donghaixiang Protective Equipment Co., Ltd.FXXClass II
K212069Corin MetaFix™ Hip StemCorin USALZOClass II
K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen or, LLCNUJClass II
K210860Comfort Guard Mask, level 1, Comfort Guard Mask, level 3GRI-Alleset, Inc.FXXClass II
K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis US Corp.NTEClass II
K220625ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemRemed Co., Ltd.OBPClass II
K214114Prodigy Thrombectomy SystemTruvic Medical, Inc.QEWClass II
K214085Disposable Medical MaskHubei Wanli Protective Products Co.,LtdFXXClass II
K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader3M CompanyFRCClass II