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
169609–169632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1979
A-GENT QUANTICHROM T4 11A
K790848 · KLI
Abbott Laboratories
Chemistry · 99d
Cleared Aug 10, 1979
QUANTIMUNE T-3 FIA
K790960 · CDP
Bio-Rad
Chemistry · 80d
Cleared Aug 10, 1979
CHEMODENT CERAMIC METAL
K791005 · EJS
Chemodent Dental Laboratory
Dental · 72d
Cleared Aug 10, 1979
SCI-PHARM PAINT-ON RESTORATIVE
K791067 · EBD
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Aug 10, 1979
ANTERIOR/POSTERIOR RESTORATIVE, BOND
K791078 · EBD
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Aug 10, 1979
LITHICRON MODEL 0401, PACEMAKER
K791095 · DXY
Medcor, Inc.
Cardiovascular · 59d
Cleared Aug 10, 1979
STERILE, DISPOSABLE CENTRIFUGE BOWL
K791106 · GKT
Travenol Laboratories, S.A.
Hematology · 58d
Cleared Aug 10, 1979
SCI-PHARM ORTHODONTIC ADHESIVE
K791132 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 53d
Cleared Aug 10, 1979
BILIRUBIN CALIBRATOR CONTROL
K791141 · JJX
Beckman Instruments, Inc.
Chemistry · 53d
Cleared Aug 10, 1979
ANALYZER, SODIUM/POTASSIUM
K791175 · CEM
Nova Biomedical Corp.
Chemistry · 46d
Cleared Aug 10, 1979
DISPIRO
K791177 · BZG
Utah Medical Products, Inc.
Anesthesiology · 46d
Cleared Aug 10, 1979
CENTRIFICHEM SYSTEM 500
K791180 · JJG
Union Carbide Corp.
Chemistry · 46d
Cleared Aug 10, 1979
PRE-DENT
K791200 · GIM
Fichte, Graves, and Hunt
Chemistry · 43d
Cleared Aug 10, 1979
MODEL SE-1 EYEGLASS HEARING AID
K791203 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Aug 10, 1979
VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG
K791212 · HQE
Precision Medical Instruments, Inc.
Ophthalmic · 38d
Cleared Aug 10, 1979
GLUCOSE (GDH) REAGENT
K791213 · LFR
Gilford Diagnostics
Chemistry · 39d
Cleared Aug 10, 1979
MALIBU LABS MODEL 800 FINGER TIP CONT
K791224 · GEI
Malibu Laboratories
General & Plastic Surgery · 39d
Cleared Aug 10, 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
K791225 · DXY
Shiley, Inc.
Cardiovascular · 38d
Cleared Aug 10, 1979
BAYLOR VISUAL FIELDS PROGRAMMER
K791295 · HPT
Schiff Harding Waite
Ophthalmic · 31d
Cleared Aug 10, 1979
PRISMA
K791297 · JJE
Lkb Instruments, Inc.
Chemistry · 25d
Cleared Aug 10, 1979
BOWLES STETHOSCOPE
K791333 · DQD
Amdia Medical Products
Cardiovascular · 21d
Cleared Aug 10, 1979
MULTISCOPE
K791334 · DQD
Amdia Medical Products
Cardiovascular · 21d
Cleared Aug 10, 1979
NURSESCOPE
K791335 · DQD
Amdia Medical Products
Cardiovascular · 21d
Cleared Aug 10, 1979
DUAL HEAD STETHOSCOPE
K791338 · DQD
Amdia Medical Products
Cardiovascular · 21d