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
27145–27168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2017
SafeSept Transseptal Guidewire
K170671 · DRC
Pressure Products Medical Device...
Cardiovascular · 228d
Cleared Oct 20, 2017
Ultimate Contour, Ultimate Contour Mini
K171052 · PBX
CAO Group, Inc.
General & Plastic Surgery · 193d
Cleared Oct 20, 2017
D'Vill Introducer
K171206 · DYB
NuMED, Inc.
Cardiovascular · 178d
Cleared Oct 20, 2017
ClearPoint System
K171257 · ORR
Mri Interventions, Inc.
Neurology · 175d
Cleared Oct 20, 2017
Accuro
K171594 · IYO
Rivanna Medical, LLC
Radiology · 142d
Cleared Oct 20, 2017
BR-FHUS Viewer 1.0
K171709 · LLZ
Taihao Medical, Inc.
Radiology · 134d
Cleared Oct 20, 2017
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
K171987 · KGO
Lucenxia Prescience AG
General Hospital · 109d
Cleared Oct 20, 2017
Adani MammoScan
K172027 · MUE
Adani
Radiology · 107d
Cleared Oct 20, 2017
GuideLiner V3 Catheter
K172090 · DQY
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Oct 20, 2017
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non...
K172149 · GAP
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 95d
Cleared Oct 20, 2017
TREFOIL System
K172352 · DZE
Nobel Biocare AB
Dental · 78d
Cleared Oct 20, 2017
GSI Novus
K172403 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 72d
Cleared Oct 20, 2017
Discovery XR656 HD
K172869 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 30d
Cleared Oct 20, 2017
NeuroBlate System
K172881 · GEX
Monteris Medical,
General & Plastic Surgery · 29d
Cleared Oct 20, 2017
Heraeus TMW Guidewire
K173052 · DQX
Heraeus Medical Components, LLC
Cardiovascular · 22d
Cleared Oct 19, 2017
GRI-FILL PERISTALTIC SET
K162216 · LHI
Laboratorios Grifols, S.A.
General Hospital · 437d
Cleared Oct 19, 2017
Premium Plus Prophy Air Motor
K170261 · EFB
Premium Plus International Limited
Dental · 265d
Cleared Oct 19, 2017
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · CFR
Abbott Laboratories
Chemistry · 260d
Cleared Oct 19, 2017
Medrobotics Flex Robotic System
K170453 · EOB
Medrobotics Corporation
Ear, Nose, Throat · 246d
Cleared Oct 19, 2017
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT...
K170614 · NBW
I-Sens, Inc.
Chemistry · 232d
Cleared Oct 19, 2017
VICTUS Femtosecond Laser Platform
K171014 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 198d
Cleared Oct 19, 2017
audifon Tinnitus-Module
K171243 · KLW
Audiofon USA, Inc.
Ear, Nose, Throat · 174d
Cleared Oct 19, 2017
065 Zenith, 074 Zenith
K171672 · DQY
Inneuroco, Inc.
Cardiovascular · 135d
Cleared Oct 19, 2017
RPM Reinforced PTFE Mesh
K171774 · NPK
Osteogenics Biomedical, Inc.
Dental · 127d