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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
69553–69576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2004
PHOENIX INFUSION CATHETER
K033017 · JXG
Phoenix Biomedical
Neurology · 194d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST...
K033866 · DIO
Lin-Zhi International, Inc.
Toxicology · 117d
Cleared Apr 07, 2004
BIOFREE
K033925 · EIA
Dental Components, Inc.
Dental · 111d
Cleared Apr 07, 2004
POLYLASE LP
K040055 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Apr 07, 2004
LIFESTYLE CIRCULATORY ENHANCER
K040084 · BWF
Advanced Circulatory Systems, Inc.
Anesthesiology · 83d
Cleared Apr 07, 2004
YUE PFONG SAFETY SYRINGE (3ML)
K040105 · MEG
Yue Pfong International Industrial...
General Hospital · 78d
Cleared Apr 07, 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · KPS
GE Medical Systems
Radiology · 72d
Cleared Apr 07, 2004
CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM
K040195 · LLZ
Witt Biomedical Corp
Radiology · 70d
Cleared Apr 07, 2004
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
K040367 · BYI
Electromed, Inc.
Anesthesiology · 54d
Cleared Apr 07, 2004
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
K040385 · FPA
Quest Medical, Inc.
General Hospital · 50d
Cleared Apr 07, 2004
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
K040556 · EHD
Eastman Kodak Company
Radiology · 36d
Cleared Apr 07, 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · DTB
Oscor, Inc.
Cardiovascular · 34d
Cleared Apr 07, 2004
BLUEWAND LED DENTAL CURING WAND SYSTEM
K040614 · EBZ
J.L. Blosser, Inc.
Dental · 29d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Apr 07, 2004
BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES
K040643 · DZE
Branemark Integration AB
Dental · 27d
Cleared Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006,...
K040667 · FGE
Abbott Laboratories
Gastroenterology & Urology · 23d
Cleared Apr 07, 2004
MASTERSCREEN CPX AND OXYCON CPX
K040698 · BZC
Viasys Healthcare GmbH
Anesthesiology · 21d
Cleared Apr 07, 2004
DOSI-FUSER
K040752 · MEB
Leventon, S.A.
General Hospital · 14d
Cleared Apr 07, 2004
STRUCTUR 2 SC
K040769 · EBG
Voco GmbH
Dental · 13d
Cleared Apr 07, 2004
PROTAB ECG TABB ELECTRODE
K040784 · DRX
Bio Protech, Inc.
Cardiovascular · 9d
Cleared Apr 06, 2004
HEMOCLEAN
K023064 · NII
Krd Co., Ltd.
General Hospital · 568d
Cleared Apr 06, 2004
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 76d
Cleared Apr 06, 2004
CADIMPLANT
K040224 · JAK
Praxim, Inc.
Radiology · 64d
Cleared Apr 06, 2004
HRV TOOLS
K040313 · DPS
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 57d