FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
22873–22896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 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
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 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