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
57985–58008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2007
MICROPROTEIN REAGENT SET
K070757 · JGP
Pointe Scientific, Inc.,
Chemistry · 259d
Cleared Dec 04, 2007
LEUKO EZ VUE
K071712 · DEG
Techlab Inc., Corporate Research Center
Immunology · 165d
Cleared Dec 04, 2007
NUVASIVE COROENT SYSTEM
K071795 · MAX
Nuvasive, Inc.
Orthopedic · 155d
Cleared Dec 04, 2007
MEMOMETAL BONE ANCHORS
K071941 · HWC
Memometal Technologies
Orthopedic · 144d
Cleared Dec 04, 2007
STANDOUT 2
K072622 · ELW
Kerr Corp.
Dental · 78d
Cleared Dec 04, 2007
E-1 ESTHETIC COMPOSITE SYSTEM
K072746 · EBF
Tokuyama Dental Corporation
Dental · 68d
Cleared Dec 04, 2007
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
K072750 · DQY
Spectranetics Corp.
Cardiovascular · 68d
Cleared Dec 04, 2007
RM BOND, MODEL J032
K072830 · DYH
Pentron Clinical Technologies
Dental · 62d
Cleared Dec 04, 2007
MILESMAN PREMIUM
K073300 · GEX
Milesman S.L.
General & Plastic Surgery · 11d
Cleared Dec 03, 2007
THERAPEUTIC MASSAGE COMPANION
K060846 · NUH
Endurance Therapeutics
Neurology · 615d
Cleared Dec 03, 2007
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
K070053 · NBW
Eps Bio Technology Corp.
Chemistry · 333d
Cleared Dec 03, 2007
CREATININE (ENZYMATIC)
K070824 · JFY
Thermofisher Scientific OY
Chemistry · 252d
Cleared Dec 03, 2007
NEURONAV SYSTEM AND NEURONAV DRIVE
K071697 · GZL
Alpha Omega , Ltd.
Neurology · 166d
Cleared Dec 03, 2007
APL MEDICAL SYSTEM
K072344 · GEX
Bios S.R.L.
General & Plastic Surgery · 104d
Cleared Dec 03, 2007
CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T
K072453 · GEH
Brymill Corp.
General & Plastic Surgery · 94d
Cleared Dec 03, 2007
MODIFICATION TO: LOCATOR IMPLANT ANCHOR
K072878 · NHA
Zest Anchors, Inc.
Dental · 55d
Cleared Dec 03, 2007
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
K073147 · MXC
Transoma Medical
Cardiovascular · 25d
Cleared Dec 03, 2007
R-PORT II LAPAROSCOPIC ACCESS DEVICE
K073170 · GCJ
Advanced Surgical Concepts
General & Plastic Surgery · 24d
Cleared Nov 30, 2007
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
K070015 · LOD
Biomet Manufacturing Corp
Orthopedic · 331d
Cleared Nov 30, 2007
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
K070705 · FOZ
Vygon Corp.
General Hospital · 261d
Cleared Nov 30, 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE...
K070900 · DFH
The Binding Site, Ltd.
Immunology · 242d
Cleared Nov 30, 2007
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
K071202 · MSD
Dermaport, Inc.
Gastroenterology & Urology · 213d
Cleared Nov 30, 2007
SMARTCHECK INR SYSTEM
K071265 · JPA
Inverness Medical Innovations, Inc.
Hematology · 207d
Cleared Nov 30, 2007
SYNTHES VECTRA-ONE SYSTEM
K071667 · KWQ
Synthes Spine
Orthopedic · 164d