Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
33913–33936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2015
JBAIDS Influenza A & B Detection Kit
K152523 · OCC
U.S Army Medical Materiel Development...
Microbiology · 28d
Cleared Sep 30, 2015
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
K140827 · LCP
Sd Biosensor, Inc.
Chemistry · 547d
Cleared Sep 30, 2015
FreeStyle Precision Neo Blood Glucose Monitoring System
K142928 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 356d
Cleared Sep 30, 2015
GPC Intramedullary Nailing Systems
K143245 · HSB
Gpc Medical Limited
Orthopedic · 322d
Cleared Sep 30, 2015
PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
K150078 · NGX
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 258d
Cleared Sep 30, 2015
Supria Whole-body X-ray CT System
K150565 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 208d
Cleared Sep 30, 2015
Q2 Intravenous Adminstration Sets and Extension Sets
K151079 · FPA
Quest Medical, Inc.
General Hospital · 161d
Cleared Sep 30, 2015
Ready-Fit
K151149 · OBR
Den Tek Oral Care, Inc.
Dental · 153d
Cleared Sep 30, 2015
MultiScan G-Arm System
K151280 · OXO
Beijing East Whale Imaging Technology...
Radiology · 139d
Cleared Sep 30, 2015
Seneka I Polyscrew Pedicle Fixation System
K151849 · NKB
Senecka Spine
Orthopedic · 85d
Cleared Sep 30, 2015
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable...
K152524 · FGE
Cook Incorporated
Gastroenterology & Urology · 27d
Cleared Sep 29, 2015
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K150622 · JOJ
3M Company
General Hospital · 202d
Cleared Sep 29, 2015
Cholesterol
K150654 · CHH
Randox Laboratories, Ltd.
Chemistry · 200d
Cleared Sep 29, 2015
HEARTWAY Power Mobility Scooter
K150998 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 167d
Cleared Sep 29, 2015
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood...
K151100 · NBW
Taidoc Technology Corporation
Chemistry · 158d
Cleared Sep 29, 2015
Neon EEG
K151576 · GXY
Incereb, Ltd.
Neurology · 110d
Cleared Sep 29, 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM...
K151579 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Sep 29, 2015
SureSigns VS3, SureSigns VS4
K151761 · DSJ
Phillips Medical Systems
Cardiovascular · 92d
Cleared Sep 29, 2015
Intradermal Adapter
K151777 · FMF
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Sep 29, 2015
LOGIQ S8
K152195 · IYN
Ge Healthcare
Radiology · 55d
Cleared Sep 29, 2015
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
K152483 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 29d
Cleared Sep 28, 2015
ARIX Ankle System
K152158 · KTT
Jeil Medical Corporation
Orthopedic · 56d
Cleared Sep 28, 2015
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
K152171 · KTT
Orthofix Srl
Orthopedic · 55d
Cleared Sep 28, 2015
Onrad Treatment System
K152488 · MUJ
Accuray Incorporated
Radiology · 28d