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
22921–22944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2019
Air Relax
K173158 · IRP
Maxstar Industrial Co., Ltd.
Physical Medicine · 608d
Cleared May 30, 2019
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with...
K182308 · LZA
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital · 279d
Cleared May 30, 2019
Qangio XA 3D
K182611 · QHA
Medis Medical Imaging Systems BV
Radiology · 251d
Cleared May 30, 2019
GaltTWS
K182660 · DRB
Galt Medical Corp.
Cardiovascular · 247d
Cleared May 30, 2019
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC...
K183205 · JQC
Emcyte Corporation
Hematology · 192d
Cleared May 30, 2019
neXus Ultrasonic Surgical Aspirator System
K190160 · LFL
Misonix, Inc.
General & Plastic Surgery · 120d
Cleared May 30, 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical...
K190623 · OCL
Medtronic
Cardiovascular · 80d
Cleared May 30, 2019
FlexSeal Introducer Sheath with Hydrophilic Coating
K190628 · DYB
Freudenberg Medical Mis, Inc.
Cardiovascular · 79d
Cleared May 30, 2019
Arc Endocuff Glide AEG110 & AEG120
K191067 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 38d
Cleared May 30, 2019
MasterLoc Extension
K191145 · LZO
Medacta International S.A.
Orthopedic · 30d
Cleared May 30, 2019
ASHK100G
K191188 · LLZ
Lg Electronics
Radiology · 27d
Cleared May 29, 2019
Revolution External Plating System
K181630 · KTT
New Standard Device Dba Metalogix
Orthopedic · 343d
Cleared May 29, 2019
Peel-Away Introducer
K182403 · FED
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared May 29, 2019
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D,...
K182526 · KNG
Vcomin Technology Limited
Obstetrics & Gynecology · 260d
Cleared May 29, 2019
Brain Perfusion (BP) application
K182716 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 244d
Cleared May 29, 2019
Segmented Esophageal Stent System
K182910 · ESW
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 224d
Cleared May 29, 2019
Fuji Cervical Plate System
K183084 · KWQ
Altus Partners, LLC
Orthopedic · 204d
Cleared May 29, 2019
Entuit PEG, Entuit PEGJ
K183336 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 177d
Cleared May 29, 2019
LuxaCrown, Shade A1, A2, A3, A3.5
K183337 · EBG
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 177d
Cleared May 29, 2019
Silver High Performance Dressing
K183645 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 154d
Cleared May 29, 2019
MitraClip G4 Steerable Guide Catheter
K190167 · DRA
Abbott
Cardiovascular · 118d
Cleared May 29, 2019
GuttaSil
K190510 · KIF
Meta Biomed Co., Ltd.
Dental · 89d
Cleared May 29, 2019
Manual Wheelchair SIVFH2A102
K190534 · IOR
Jiangsu Horizon Medical Science &...
Physical Medicine · 86d
Cleared May 29, 2019
Juliet® Ti LL Lumbar Interbody Device
K190877 · OVD
Spineart
Orthopedic · 55d