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
32809–32832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2016
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · KGE
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 262d
Cleared Feb 18, 2016
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
K151817 · NGZ
bioMerieux, Inc.
Microbiology · 227d
Cleared Feb 18, 2016
Triumph Resin Dam
K151945 · EIE
Denali Corporation
Dental · 219d
Cleared Feb 18, 2016
Recovery Cone Removal System
K152136 · MMX
C.R. Bard, Inc.
Cardiovascular · 202d
Cleared Feb 18, 2016
Erchonia EVRL
K152196 · NHN
Erchonia Corporation
Physical Medicine · 197d
Cleared Feb 18, 2016
Ennova Self-adhesive Electrode
K152648 · GXY
Suzhou Ennova Electronics Technology...
Neurology · 155d
Cleared Feb 18, 2016
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
K152702 · GEI
Ent Biotech Solutions
General & Plastic Surgery · 150d
Cleared Feb 18, 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 140d
Cleared Feb 18, 2016
Alpine Cemented Hip System
K153216 · JDI
Ortho Development Corporation
Orthopedic · 105d
Cleared Feb 18, 2016
Fusion Compact Navigation System
K153247 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 101d
Cleared Feb 18, 2016
OS2-C Compression Staple
K153395 · JDR
In2bones Sas
Orthopedic · 86d
Cleared Feb 18, 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for...
K153442 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 83d
Cleared Feb 18, 2016
Optimus ALIF System
K160291 · OVD
Amendia, Inc.
Orthopedic · 15d
Cleared Feb 17, 2016
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165 · GAR
Aesculap, Inc.
General & Plastic Surgery · 292d
Cleared Feb 17, 2016
FREND™ Free T4 Test System
K152422 · CEC
Nanoentek USA, Inc.
Chemistry · 175d
Cleared Feb 17, 2016
ROP Resorbable Hemostasis Material
K153095 · MTJ
Resorbable Orthopedic Products, LLC
General & Plastic Surgery · 114d
Cleared Feb 17, 2016
VitalStim(R) Plus Electrotherapy System
K153224 · IPF
Djo, LLC
Physical Medicine · 103d
Cleared Feb 17, 2016
CliniscanSM MRI
K153593 · LLZ
Picofemto, LLC
Radiology · 63d
Cleared Feb 17, 2016
ST AIA-PACK hsE2 Calibrator Set
K160113 · JIT
Tosoh Bioscience, Inc.
Chemistry · 29d
Cleared Feb 16, 2016
AnapnoGuard 100 Respiratory Guard System
K150157 · BSK
Hospitech Respiration , Ltd.
Anesthesiology · 389d
Cleared Feb 16, 2016
D.N.E. External Fixation System
K151580 · KTT
Dne, LLC
Orthopedic · 250d
Cleared Feb 16, 2016
Direct Bilirubin
K152343 · JFM
Randox Laboratories Limited
Chemistry · 181d
Cleared Feb 16, 2016
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System -...
K152485 · LOX
Ostial Corporation
Cardiovascular · 169d
Cleared Feb 16, 2016
Radiance V3
K153368 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 85d