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
50929–50952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2010
IGUIDE CAPPA
K093787 · JAK
Cas Innovations GmbH & Co. KG
Radiology · 92d
Cleared Mar 11, 2010
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
K093864 · MAX
Stryker Corp.
Orthopedic · 84d
Cleared Mar 11, 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · MNI
Spineart
Orthopedic · 79d
Cleared Mar 11, 2010
CARESTREAM IMAGE SUITE
K100094 · LLZ
Carestream Heatlh, Inc.
Radiology · 57d
Cleared Mar 11, 2010
DIAGNOSOFT HARP MODEL 2.06
K100352 · LNH
Diagnosoft, Inc.
Radiology · 27d
Cleared Mar 10, 2010
FIXIT HEADREST CLAMP SYSTEM
K083803 · HBL
Medicon EG
Neurology · 443d
Cleared Mar 10, 2010
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
K091520 · MVM
Immco Diagnostics, Inc.
Immunology · 292d
Cleared Mar 10, 2010
INTEGRATED LABORATORY AUTOMATION SOLUTION
K091975 · CGA
Integrated Laboratory Automation...
Chemistry · 252d
Cleared Mar 10, 2010
CLARUJUST
K092089 · EWO
Audigence, Inc.
Ear, Nose, Throat · 244d
Cleared Mar 10, 2010
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
K092141 · LBH
3M Espe Dental Products
Dental · 238d
Cleared Mar 10, 2010
BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300
K092383 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 217d
Cleared Mar 10, 2010
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND...
K092409 · CAH
Intersurgical, Inc.
General Hospital · 216d
Cleared Mar 10, 2010
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
K092414 · KCT
Conmed Corporation
General Hospital · 215d
Cleared Mar 10, 2010
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K092545 · MRN
Ino Therapeutics, LLC
Anesthesiology · 203d
Cleared Mar 10, 2010
INBODY, MODELS: 270, R20, R20B
K092786 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 181d
Cleared Mar 10, 2010
NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO,...
K092908 · FMF
Neomed, Inc.
General Hospital · 169d
Cleared Mar 10, 2010
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
K092930 · FPA
Nexus Medical, LLC
General Hospital · 169d
Cleared Mar 10, 2010
PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL...
K093124 · BZD
Cardinal Health 207, Inc.
Anesthesiology · 159d
Cleared Mar 10, 2010
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
K093384 · JJY
Diamond Diagnostics, Inc.
Chemistry · 131d
Cleared Mar 10, 2010
OLYMPUS CHF TYPE Y0003
K093507 · FBN
Olympus Medical Systems Corporation
Gastroenterology & Urology · 117d
Cleared Mar 10, 2010
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C....
K093526 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 114d
Cleared Mar 10, 2010
PULPDENT FLUORIDE VARNISH
K093620 · LBH
Pulpdent Corporation
Dental · 107d
Cleared Mar 10, 2010
TELIO CAD
K093708 · EBG
Ivoclar Vivadent, Inc.
Dental · 98d
Cleared Mar 10, 2010
EXCITE F AND EXCITE DSC
K093744 · KLE
Ivoclar Vivadent, Inc.
Dental · 96d