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

Filters: Cleared only ×
176,076 results
76705–76728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2002
AQUIFY LENS COMFORT DROPS
K013204 · MRC
Ciba Vision Corporation
Ophthalmic · 190d
Cleared Apr 03, 2002
RIGID GAS PERMEABLE CONTACT LENS
K013762 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 141d
Cleared Apr 03, 2002
CARIS MINITOME BIOPSY INSTRUMENT
K020024 · KNW
Artemis Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 03, 2002
MFCD 118I
K020059 · LLZ
Barco N.V.
Radiology · 85d
Cleared Apr 03, 2002
IMAGEDESK
K020061 · LLZ
Barco N.V.
Radiology · 85d
Cleared Apr 03, 2002
MODIFICATION TO TRELEX MESH SURGICAL MESH
K020110 · OTN
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Apr 03, 2002
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147 · FMF
Medtronic Perfusion Systems
General Hospital · 77d
Cleared Apr 03, 2002
REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S...
K020308 · KGO
Ssl America'S, Inc.
General Hospital · 64d
Cleared Apr 03, 2002
UPLINK TEST SYSTEM
K020371 · DJG
OraSure Technologies, Inc.
Toxicology · 58d
Cleared Apr 03, 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 51d
Cleared Apr 03, 2002
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
K020592 · DWL
Alba-Waldensian, Inc.
General Hospital · 40d
Cleared Apr 03, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K020674 · MNH
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared Apr 03, 2002
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681 · MNH
Ebi, L.P.
Orthopedic · 30d
Cleared Apr 03, 2002
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
K020688 · HRX
Hydrocision, Inc.
Orthopedic · 30d
Cleared Apr 03, 2002
POWER TEK II
K020761 · HRX
Biomet, Inc.
Orthopedic · 27d
Cleared Apr 03, 2002
ADVANTA SST BIFURCATED GRAFT
K020767 · DSY
Atrium Medical Corp.
Cardiovascular · 26d
Cleared Apr 03, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · DLJ
Lin-Zhi International, Inc.
Toxicology · 27d
Cleared Apr 03, 2002
CT-C3000 SPIRAL CT SCANNER SYSTEM
K020913 · JAK
Neusoft Digital Medical Systems Co.,...
Radiology · 13d
Cleared Apr 03, 2002
SMARTSCORE 3.5
K020929 · JAK
GE Medical Systems
Radiology · 12d
Cleared Apr 03, 2002
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
K020935 · CGA
Hemocue, Inc.
Chemistry · 12d
Cleared Apr 02, 2002
MULTI HI-FLO PNEU, WISAP #7080
K011510 · HIF
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 321d
Cleared Apr 02, 2002
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · MYI
Oxoid , Ltd.
Microbiology · 302d
Cleared Apr 02, 2002
IMMUNE CELL FUNCTION ASSAY
K013169 · NID
Cylex, Inc.
Hematology · 193d
Cleared Apr 02, 2002
CROSSPOINT TRANSACCESS CATHETER
K013363 · ITX
Trans Vascular Incorporated
Radiology · 174d