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
24049–24072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 2019
Optimus Neuro System
K183352 · GWO
Osteonic Co., Ltd.
Neurology · 30d
Cleared Jan 02, 2019
3M Filtek Universal Restorative
K183476 · EBF
3M Espe Dental Products
Dental · 16d
Cleared Jan 02, 2019
Signature Orthodontic System
K183542 · NJM
Signature Orthodontics
Dental · 13d
Cleared Dec 31, 2018
Zenition 50
K183101 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 54d
Cleared Dec 29, 2018
ViperCath XC Peripheral Exchange Catheter
K183000 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 60d
Cleared Dec 28, 2018
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
K180204 · JEY
Visionare, LLC
Dental · 338d
Cleared Dec 28, 2018
AmCAD-UO
K180867 · LLZ
Amcad Biomed Corporation
Radiology · 270d
Cleared Dec 28, 2018
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
K181703 · DZE
Institut Straumann AG
Dental · 184d
Cleared Dec 28, 2018
OIC Suture Anchor System
K182736 · MBI
The Orthopaedic Implant Company
Orthopedic · 91d
Cleared Dec 28, 2018
COR12 ECG
K183369 · DPS
Corscience GmbH & Co.
Cardiovascular · 24d
Cleared Dec 27, 2018
Lotus III Multi-Pulsed Er: Yag Laser System
K182045 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 150d
Cleared Dec 27, 2018
iSchemaView RAPID
K182130 · LLZ
Ischemaview, Inc.
Radiology · 143d
Cleared Dec 27, 2018
STERRAD VELOCITY Biological Indicator
K182404 · FRC
Advanced Sterilization Products (Asp)
General Hospital · 114d
Cleared Dec 27, 2018
LATITUDE EV Total Elbow Arthroplasty
K182461 · JDB
Tornier, Inc.
Orthopedic · 108d
Cleared Dec 27, 2018
Quantib ND
K182564 · LLZ
Quantib B.V.
Radiology · 100d
Cleared Dec 27, 2018
minisono
K182845 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 79d
Cleared Dec 27, 2018
Pulse 2.0, Pulse Pro 2.0
K183169 · IRP
NormaTec Industries, LP
Physical Medicine · 41d
Cleared Dec 26, 2018
Zimmer Biomet Select Ceramic Heads
K181761 · LZO
Zimmer, Inc.
Orthopedic · 176d
Cleared Dec 26, 2018
Delta TT Pro
K182099 · LPH
Lima Corporate S.P.A.
Orthopedic · 145d
Cleared Dec 26, 2018
VO200 – NeurOs Cerebral Oximetry System
K182242 · QEM
Mespere Lifesciences, Inc.
General & Plastic Surgery · 128d
Cleared CT Dec 26, 2018
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin...
K182698 · NXO
DiaSorin, Inc.
Immunology · 90d
Cleared Dec 26, 2018
One-Step Suprapubic Introducer
K182709 · KOB
Cook Incorporated
Gastroenterology & Urology · 90d
Cleared Dec 26, 2018
DePuy Synthes Trauma Orthopedic Nail Implants
K182783 · HRS
DePuy Synthes
Orthopedic · 86d
Cleared Dec 24, 2018
QuikClot Radial
K181641 · QSY
Z-Medica, LLC
General & Plastic Surgery · 186d