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
25273–25296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2018
Curiteva Anterior Cervical Plate System
K181562 · KWQ
Curiteva, LLC
Orthopedic · 49d
Cleared Aug 02, 2018
Alphenix, INFX-8000C/B, V8.0
K181804 · OWB
Canon Medical Systems Corporation
Radiology · 27d
Cleared Aug 02, 2018
Azurion R2.0
K181830 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 24d
Cleared Aug 01, 2018
BriefCase
K180647 · QAS
Aidoc Medical , Ltd.
Radiology · 142d
Cleared Aug 01, 2018
VITA YZ ST and VITA YZ XT
K180703 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 135d
Cleared Aug 01, 2018
Ultrasound Scanner System bk2300
K180737 · IYN
Bk Medical Aps
Radiology · 132d
Cleared Aug 01, 2018
TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
K180764 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 131d
Cleared Aug 01, 2018
Propeller Sensor for Neohaler
K180770 · CAF
Reciprocal Labs Corporation
Anesthesiology · 131d
Cleared Aug 01, 2018
MMD Tip
K181480 · GEX
Strata Skin Sciences, Inc.
General & Plastic Surgery · 57d
Cleared Aug 01, 2018
Smart One
K181666 · BZH
Mir Medical International Research
Anesthesiology · 37d
Cleared Aug 01, 2018
SuperCable® Iso-Elastic™ Cerclage System
K181749 · JDQ
Kinamed, Incorporated
Orthopedic · 30d
Cleared Aug 01, 2018
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
K181772 · GAT
Ceterix Orthopaedics, Inc.
General & Plastic Surgery · 29d
Cleared Jul 31, 2018
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with...
K180874 · FXX
3M Healthcare
General Hospital · 119d
Cleared Jul 31, 2018
Picocare Family
K181272 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 78d
Cleared Jul 31, 2018
SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve...
K181422 · NHI
Spr Therapeutics, Inc.
Neurology · 61d
Cleared Jul 31, 2018
MTS Plazomicin 0.016-256 µg/mL
K181708 · JWY
Liofilchem S. R. L.
Microbiology · 33d
Cleared Jul 30, 2018
308nm Excimer System
K172273 · FTC
Chongqing Peninsula Medical...
General & Plastic Surgery · 367d
Cleared Jul 30, 2018
TE7/TE5 Diagnostic Ultrasound System
K180912 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 115d
Cleared Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · LFZ
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Jul 30, 2018
Laser Ureteral Catheter
K181431 · GEX
Cook Incorporated
Gastroenterology & Urology · 59d
Cleared Jul 30, 2018
Proficient® Posterior Cervical Spine System
K181440 · NKG
Spine Wave, Inc.
Orthopedic · 59d
Cleared Jul 30, 2018
Epiphany Cardio Server Mobile
K181720 · DQK
Epiphany Healthcare, LLC
Cardiovascular · 31d
Cleared Jul 30, 2018
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B...
K181736 · OZE
Centers For Disease Control and...
Microbiology · 28d
Cleared Jul 30, 2018
IceSphere 1.5 CX Cryoablation Needle
K181741 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 28d