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
20593–20616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2020
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair...
K193105 · JWH
Conformis, Inc.
Orthopedic · 126d
Cleared Mar 13, 2020
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K193110 · QKM
3M Healthcare
General Hospital · 122d
Cleared CT Mar 13, 2020
Indigo Aspiration System – Lightning Aspiration Tubing
K193244 · QEW
Penumbra, Inc.
Cardiovascular · 109d
Cleared Mar 13, 2020
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System...
K193325 · KNT
Prosys International, Ltd.
Gastroenterology & Urology · 102d
Cleared Mar 13, 2020
SeaSpine Skipjack System
K193418 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 95d
Cleared Mar 13, 2020
PrisMax System Version 3
K193482 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 87d
Cleared Mar 13, 2020
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
K193572 · LON
bioMerieux, Inc.
Microbiology · 81d
Cleared Mar 13, 2020
Disposable SpO2 Sensor
K200069 · DQA
Shenzhen Changke Connect Electronics...
Anesthesiology · 60d
Cleared Mar 13, 2020
3DMetal Diaphyseal Femoral Cones
K200075 · JWH
Medacta International S.A.
Orthopedic · 59d
Cleared Mar 13, 2020
CS 9600
K200183 · OAS
Trophy
Radiology · 49d
Cleared Mar 13, 2020
Stat Profile Prime Plus Analyzer System
K200349 · CGA
Nova Biomedical Corporation
Chemistry · 30d
Cleared Mar 13, 2020
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula,...
K200358 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Mar 13, 2020
LEGION Inserts with JRNY Lock
K200407 · JWH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Mar 12, 2020
RefleXion Medical Radiotherapy System
K190978 · IYE
Reflexion Medical, Inc.
Radiology · 332d
Cleared Mar 12, 2020
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638 · DIO
Medtest DX
Toxicology · 267d
Cleared Mar 12, 2020
SpaceStation MRI
K191910 · MRZ
B. Braun Melsugen AG
General Hospital · 239d
Cleared Mar 12, 2020
NEOLab Clear Aligners
K192338 · NXC
New England Ortho Lab, Inc.
Dental · 197d
Cleared Mar 12, 2020
SonoVision Ultrasound Imaging System
K192388 · IYN
Tissue Differentiation Intelligence, LLC
Radiology · 191d
Cleared Mar 12, 2020
elysion-pro
K193367 · GEX
High Technology Products S.L.U
General & Plastic Surgery · 99d
Cleared Mar 12, 2020
BioNourish Lubricant
K193448 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 12, 2020
Tritium Sternal Cable Plate System
K193468 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 87d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K193538 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 12, 2020
AMT Suture Delivery System
K193612 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 12, 2020
Health Line CT Midline Catheter
K200263 · FOZ
Health Line International Corporation
General Hospital · 38d