FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23449–23472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2019
ExpanSure Transseptal Dilation System
K182064 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 232d
Cleared Mar 21, 2019
Mineral Collagen Composite Bioactive Moldable
K182074 · MQV
Collagen Matrix, Inc.
Orthopedic · 232d
Cleared Mar 21, 2019
Ballast 088 Long Sheath
K182918 · DQY
Balt USA, LLC
Neurology · 153d
Cleared Mar 21, 2019
MPACT Extension
K183582 · LPH
Medacta International S.A.
Orthopedic · 90d
Cleared CT Mar 21, 2019
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow...
K183592 · PWD
Beckman Coulter
Immunology · 90d
Cleared Mar 21, 2019
UroLift System UL400
K190377 · PEW
Neotract, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 21, 2019
nvc
K190380 · ODP
Nvision Biomedical Technologies, Inc.
Orthopedic · 30d
Cleared Mar 21, 2019
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K190412 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 28d
Cleared Mar 21, 2019
NuVasive® VersaTie® System
K190418 · OWI
Nu Vasive, Incorporated
Orthopedic · 28d
Cleared Mar 21, 2019
CastleLoc-P Anterior Cervical Plate System
K190425 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 27d
Cleared Mar 21, 2019
Route 92 Medical Delivery Catheter
K190431 · DQY
Route 92 Medical, Inc.
Neurology · 27d
Cleared Mar 20, 2019
SimplCath
K182511 · GBM
F&S Medical Solutions, LLC
Gastroenterology & Urology · 189d
Cleared Mar 20, 2019
BD Nexiva Closed IV Catheter System
K183399 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 103d
Cleared Mar 20, 2019
Jensen Shade Effect Liquids
K183408 · EIH
Jensen Industries, Inc.
Dental · 100d
Cleared Mar 20, 2019
ABSOLU
K183414 · IYO
Quantel Medical
Radiology · 100d
Cleared Mar 20, 2019
ACTIV.A.C. Therapy Unit
K183543 · OMP
Kci USA, Inc.
General & Plastic Surgery · 90d
Cleared Mar 20, 2019
ACUSON S3000, S2000 Diagnostic Ultrasound System
K183575 · IYN
Siemens Healthineers
Radiology · 89d
Cleared Mar 19, 2019
SERVO-U Ventilator System version 2.1
K180098 · CBK
Maquet Critical Care AB
Anesthesiology · 427d
Cleared Mar 19, 2019
Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy...
K182383 · LZC
Yty Industry (Manjung) Sdn Bhd
General Hospital · 200d
Cleared Mar 19, 2019
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II...
K182468 · LPH
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 190d
Cleared Mar 19, 2019
AP3600 Automated Instrument
K182793 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 169d
Cleared CT Mar 19, 2019
SIS Software version 3.3.0
K183019 · LLZ
Surgical Information Sciences, Inc.
Radiology · 139d
Cleared Mar 19, 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527 · JWY
Liofilchem S. R. L.
Microbiology · 90d
Cleared Mar 19, 2019
AE-120A EEG Head Set
K183529 · OMC
Nihon Kohden Corporation
Neurology · 90d