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
23473–23496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2019
MIM on Linux
K190379 · LLZ
Mim Software, Inc.
Radiology · 28d
Cleared Mar 19, 2019
Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
K190423 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 25d
Cleared CT Mar 18, 2019
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
K181599 · QFS
Beckman Coulter
Microbiology · 273d
Cleared Mar 18, 2019
Sensilight Pro / Pistol IPL
K183260 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 115d
Cleared Mar 18, 2019
REAL Immersive System
K183296 · ISD
Penumbra, Inc.
Physical Medicine · 111d
Cleared Mar 18, 2019
The Progressive Orthopaedic Company Total Knee System II
K183344 · JWH
The Progressive Orthopaedic Company, LLC
Orthopedic · 105d
Cleared Mar 18, 2019
Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity...
K183511 · DTZ
Medtronic, Inc.
Cardiovascular · 90d
Cleared Mar 18, 2019
Preat Abutments
K183518 · NHA
Preat Corporation
Dental · 90d
Cleared Mar 18, 2019
ID NOW Influenza A & B 2
K190204 · OZE
Alere Scarborough, Inc.
Microbiology · 42d
Cleared Mar 18, 2019
Paradigm All-Suture Anchor 1.8mm, White/Black #2
K190333 · MBI
Conmed Corporation
Orthopedic · 32d
Cleared Mar 18, 2019
BRAUN Silk.expert Pro 5
K190354 · OHT
Cyden Limited
General & Plastic Surgery · 31d
Cleared Mar 18, 2019
Zavation Spinal System
K190361 · NKB
Zavation Medical Products, LLC
Orthopedic · 31d
Cleared Mar 18, 2019
BRAUN Silk Expert Pro 3
K190366 · OHT
Cyden Limited
General & Plastic Surgery · 31d
Cleared Mar 16, 2019
Sonendo GentleWave System
K190359 · ELC
Sonendo, Inc.
Dental · 29d
Cleared Mar 15, 2019
TCAT (R) THA Instrument Tray Set
K180127 · KCT
THINK Surgical, Inc.
General Hospital · 422d
Cleared Mar 15, 2019
MTF Pre-Sutured Tendon
K181633 · GAT
Musculoskeletal Transplant Foundation
General & Plastic Surgery · 268d
Cleared Mar 15, 2019
ApexMV
K182022 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 231d
Cleared Mar 15, 2019
CardioFlux with Faraday Analytical Cloud
K182571 · DPS
Genetesis, Inc.
Cardiovascular · 178d
Cleared Mar 15, 2019
MOBILETT Elara Max
K182639 · IZL
Siemens Medi Cal Solutions, Inc.
Radiology · 172d
Cleared Mar 15, 2019
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
K182813 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 163d
Cleared Mar 15, 2019
HORIZON TMS Therapy System
K182853 · OBP
Magstim Company, Ltd.
Neurology · 156d
Cleared Mar 15, 2019
nextaro Transfer System, nextaro va
K183187 · LHI
Sfm Medical Devices GmbH
General Hospital · 116d
Cleared Mar 15, 2019
MectaLIF Anterior Stand Alone Extension
K183426 · OVD
Medacta International S.A.
Orthopedic · 94d
Cleared Mar 15, 2019
SelectSite C304-HIS Deflectable Catheter System
K183493 · DQY
Medtronic, Inc.
Cardiovascular · 88d