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
49585–49608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 2010
PRECICONTROL CLINCHEM MULTI 1 AND 2
K102016 · JJY
Roche Diagnostics
Chemistry · 44d
Cleared Sep 01, 2010
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
K102020 · KWP
Spinefrontier, Inc.
Orthopedic · 44d
Cleared Sep 01, 2010
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH)...
K102176 · DRA
Medtronic Cryocath, LP
Cardiovascular · 29d
Cleared Aug 31, 2010
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
K091539 · GKL
Iris Diagnostics
Hematology · 462d
Cleared Aug 31, 2010
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
K093689 · MOS
Mr Medical Solutions, LLC
Radiology · 274d
Cleared Aug 31, 2010
CS-SERIES-FP
K100102 · OWB
Omega Medical Imaging, Inc.
Radiology · 230d
Cleared Aug 31, 2010
FASTX STERNAL INTRAOSSEOUS DEVICE
K100124 · FMI
Pyng Medical Corp.
General Hospital · 224d
Cleared Aug 31, 2010
GELSCAN, MODEL 1206
K100307 · CFE
Sebia
Chemistry · 209d
Cleared Aug 31, 2010
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
K100518 · DWP
Instrumed International, Inc.
Cardiovascular · 189d
Cleared Aug 31, 2010
FREQUENCER MODEL V2X
K100749 · BYI
Dymedso, Inc.
Anesthesiology · 168d
Cleared Aug 31, 2010
EXPEDIUM SPINE SYSTEM
K101070 · NKB
Medos International SARL
Orthopedic · 137d
Cleared Aug 31, 2010
AUDIT MICROCV RF/CRP LINEARITY SET
K101226 · JJY
Aalto Scientific, Ltd.
Immunology · 120d
Cleared Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339 · DQX
Medtronic, Inc.
Cardiovascular · 111d
Cleared Aug 31, 2010
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216,...
K101600 · DQA
Philips Medizinsysteme Boeblingen...
Anesthesiology · 84d
Cleared Aug 31, 2010
MYLABONE ULTRASOUND SYSTEM
K101605 · IYN
Esaote Europe B.V.
Radiology · 84d
Cleared Aug 31, 2010
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
K101714 · NHA
Nobel Biocare AB
Dental · 74d
Cleared Aug 31, 2010
GE LOGIQ P5 MODEL H44662LD
K101878 · IYN
Ge Healthcare
Radiology · 56d
Cleared Aug 31, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
K101950 · DXN
Andon Health Co, Ltd.
Cardiovascular · 50d
Cleared Aug 31, 2010
TENS STIMULATOR, MODELS 2800 AND 3000
K102014 · GZJ
Koalaty Products, Inc.
Neurology · 46d
Cleared Aug 31, 2010
ELECSYS DIGOXIN CALCHECK 5
K102044 · JJX
Roche Diagnostics
Chemistry · 41d
Cleared Aug 31, 2010
MR RADIATION ONCOLOGY OPTIONS
K102155 · LNH
Ge Medical Systems, LLC
Radiology · 32d
Cleared Aug 30, 2010
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 385d
Cleared Aug 30, 2010
CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C,...
K093725 · FAJ
Canada Endoscope Corporation
Gastroenterology & Urology · 270d
Cleared Aug 30, 2010
BLOOD PRESSURE METER, MODEL CH-609
K100055 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 234d