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
18817–18840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2020
coraForce and coraFlex Support Catheters
K201811 · DQY
Reflow Medical, Inc.
Cardiovascular · 117d
Cleared Oct 26, 2020
DOLOMITE Anterior Cervical Stabilization System
K202065 · OVE
Astura Medical, LLC
Orthopedic · 91d
Cleared Oct 26, 2020
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with...
K202179 · LYZ
Medline Industries, Inc.
General Hospital · 83d
Cleared Oct 26, 2020
G-EYE System
K202469 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 60d
Cleared Oct 26, 2020
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
K202489 · HRS
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 56d
Cleared Oct 26, 2020
Cannulated Power Driver Attachment
K202528 · NKB
K2m, Inc.
Orthopedic · 55d
Cleared Oct 26, 2020
1212FCA
K202722 · MQB
Rayence Co., Ltd.
Radiology · 39d
Cleared Oct 24, 2020
Li-Battery powered OTC TENS/EMS Combination Stimulator
K201335 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 157d
Cleared Oct 23, 2020
Planmed Clarity 2D and Clarity S
K192317 · MUE
Planmed OY
Radiology · 424d
Cleared Oct 23, 2020
BenestaTM Tissue Removal Device
K192811 · HIH
Caldera Medical, Inc.
Obstetrics & Gynecology · 389d
Cleared Oct 23, 2020
MaxZero Extension Sets with Needle-Free Connector(s)
K193088 · FPA
Carefusion, Inc.
General Hospital · 352d
Cleared Oct 23, 2020
V-Mix
K193357 · KJJ
Inter-Med/Vista Dental Products
Dental · 324d
Cleared Oct 23, 2020
Cryocheck Hex LA
K193556 · GFO
Precision Biologic
Hematology · 305d
Cleared Oct 23, 2020
OXY-1 System
K200109 · DTZ
Abiomed, Inc.
Cardiovascular · 280d
Cleared Oct 23, 2020
PocketDoc™ Micro Wound Therapy System
K200223 · OMP
Pensar Medical, LLC
General & Plastic Surgery · 268d
Cleared Oct 23, 2020
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA,...
K200249 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 263d
Cleared CT Oct 23, 2020
Nerivio
K201824 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 114d
Cleared Oct 23, 2020
Infrared ear and forehead thermometer, model YI-100
K201843 · FLL
Wenzhou Yosun Medical Technology Co.,Ltd
General Hospital · 109d
Cleared Oct 23, 2020
SURGIPHOR Wound Irrigation System
K202071 · FQH
Orthophor, LLC
General & Plastic Surgery · 88d
Cleared Oct 23, 2020
SIR-Spheres Microspheres Activity Calculator (SMAC)
K202392 · KPS
Sirtex Medical US Holdings, Inc.
Radiology · 63d
Cleared Oct 23, 2020
Mobio Total Knee System
K202429 · JWH
B-One Ortho, Corp.
Orthopedic · 59d
Cleared Oct 23, 2020
Drakon and Sequre Microcatheters
K202797 · DQO
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 30d
Cleared Oct 23, 2020
Wiltrom Spinal Fixation System
K202894 · NKB
Wiltrom Corporation Limited
Orthopedic · 25d
Cleared Oct 22, 2020
DIOnavi-Denture
K193623 · EBI
Dio Corporation
Dental · 301d