FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
19849–19872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2020
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
K192490 · GAT
Teleflex Medical
General & Plastic Surgery · 201d
Cleared Mar 30, 2020
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
K192640 · HGX
Guangzhou Yongyi Industrial Co., Ltd.
Obstetrics & Gynecology · 188d
Cleared Mar 30, 2020
T-Line Hernia Mesh
K193144 · FTL
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 138d
Cleared Mar 30, 2020
Agilon Strip
K193487 · MQV
Biogennix, LLC
Orthopedic · 104d
Cleared Mar 30, 2020
NuVasive Cohere Thoracolumbar Interbody System
K193541 · MAX
Nu Vasive, Incorporated
Orthopedic · 101d
Cleared Mar 30, 2020
Universal Base Conical Connection (CC)
K200040 · NHA
Nobel Biocare AG
Dental · 82d
Cleared Mar 29, 2020
Torc Body
K192039 · NGX
Johari Digital Healthcare Limited
Physical Medicine · 243d
Cleared Mar 29, 2020
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE...
K200494 · MHX
Ge Healthcare
Cardiovascular · 30d
Cleared Mar 29, 2020
QuickDraw Venous Cannula
K200499 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Mar 28, 2020
MRI ECG Patient Cable
K192852 · LNH
Ivy Biomedical Systems, Inc.
Cardiovascular · 177d
Cleared Mar 27, 2020
Diapaste
K190091 · KIF
DiaDent Group International
Dental · 434d
Cleared Mar 27, 2020
PregSense
K191401 · LQK
Nuvo- Group , Ltd.
Obstetrics & Gynecology · 308d
Cleared Mar 27, 2020
Single Use Grasping Forceps
K191900 · OCZ
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 255d
Cleared Mar 27, 2020
BiWaze Cough
K191912 · NHJ
Abmrc, LLC
Anesthesiology · 254d
Cleared Mar 27, 2020
JJ Series Container System
K192056 · KCT
Aesculap, Inc.
General Hospital · 239d
Cleared Mar 27, 2020
RAPIDPoint 500e Blood Gas System
K192240 · CHL
Siemens Healthcare Diagnostics, Inc.
Chemistry · 221d
Cleared Mar 27, 2020
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable...
K192389 · FTL
Medtronic, Inc.
General & Plastic Surgery · 206d
Cleared Mar 27, 2020
HBP6 Settable, Resorbable Hemostatic Bone Paste
K193052 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 147d
Cleared Mar 27, 2020
uMR Omega
K193200 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared Mar 27, 2020
SkyPulse
K193656 · GEX
Fotona D.O.O.
General & Plastic Surgery · 88d
Cleared Mar 27, 2020
Silhouette Instalift
K200140 · GAM
Silhouette Lift, Inc.
General & Plastic Surgery · 66d
Cleared Mar 27, 2020
GrandioSO Light Flow
K200294 · EBF
Voco GmbH
Dental · 51d
Cleared Mar 27, 2020
StimRouter Neuromodulation System
K200482 · GZF
Bioness, Inc.
Neurology · 29d
Cleared Mar 27, 2020
CUBEScan BioCon-1100
K200548 · IYO
Mcube Technology Co., Ltd.
Radiology · 24d