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
25033–25056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2018
AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
K181814 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 02, 2018
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
K181167 · EIH
Liaoning Upcera Co., Ltd.
Dental · 123d
Cleared Sep 01, 2018
Cadwell Zenith System
K181466 · GWQ
Cadwell Industries, Inc.
Neurology · 89d
Cleared Aug 31, 2018
Intelligent Mesh Nebulizer
K171549 · CAF
Qingdao Future Medical Technology...
Anesthesiology · 462d
Cleared Aug 31, 2018
Reusable & Disposable SpO2 Sensors
K173368 · DQA
Shenzhen Coreray Technology, Ltd.
Anesthesiology · 309d
Cleared Aug 31, 2018
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
K173477 · ONB
Icu Medical, Inc.
General Hospital · 291d
Cleared Aug 31, 2018
AmCAD-UT Detection 2.2
K180006 · LLZ
Amcad Biomed Corporation
Radiology · 241d
Cleared Aug 31, 2018
BIO-C REPAIR
K180185 · KIF
Angelus Industria DE Produtos...
Dental · 220d
Cleared Aug 31, 2018
CareSens S Fit Blood Glucose Monitoring System
K180866 · NBW
I-Sens, Inc.
Chemistry · 151d
Cleared Aug 31, 2018
ALTAPORE
K181225 · MQV
Baxter Healthcare Corporation
Orthopedic · 115d
Cleared CT Aug 31, 2018
IlluminOss Bone Stabilization System
K181228 · QAD
Illuminoss Medical, Inc.
Orthopedic · 115d
Cleared CT Aug 31, 2018
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464 · LYR
DiaSorin, Inc.
Microbiology · 88d
Cleared Aug 31, 2018
myTAP2
K181482 · LRK
Airway Management, Inc.
Dental · 87d
Cleared Aug 31, 2018
Cure™ OPEL-C Plate System
K181543 · KWQ
Meditech Spine, LLC
Orthopedic · 80d
Cleared Aug 31, 2018
CarriGen PF
K182107 · MQV
Etex Corporation
Orthopedic · 28d
Cleared Aug 30, 2018
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express
K173042 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 336d
Cleared Aug 30, 2018
b-ONE® Total Hip System
K173380 · LZO
B-One Ortho, Corp.
Orthopedic · 304d
Cleared Aug 30, 2018
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496 · LSR
Quidel Corporation
Microbiology · 290d
Cleared Aug 30, 2018
Anchor plate
K173623 · OAT
Biomaterials Korea, Inc.
Dental · 279d
Cleared Aug 30, 2018
Spectralis HRA + OCT and variants
K173648 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 276d
Cleared Aug 30, 2018
Neodent Implant System – GM Line
K180536 · DZE
Jjgc Industria E Comercio DE...
Dental · 183d
Cleared Aug 30, 2018
LYFT
K180888 · OLP
Uplevity, Inc.
General & Plastic Surgery · 148d
Cleared Aug 30, 2018
SpineJack Expansion Kit
K181262 · NDN
Vexim SA
Orthopedic · 111d
Cleared Aug 30, 2018
DEKA Motus AY
K181486 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 85d