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

Filters: Cleared only ×
175,820 results
17905–17928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2021
NuFACE Mini Plus
K201680 · NFO
Carole Cole Company
Neurology · 242d
Cleared Feb 19, 2021
Elos Accurate Hybrid Base
K201860 · NHA
Elos Medtech Pinol A/S
Dental · 228d
Cleared Feb 19, 2021
Safety Blood Collection Sets for Single Use
K202188 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 199d
Cleared Feb 19, 2021
TruPlan
K202212 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 197d
Cleared Feb 19, 2021
Comprehensive Vault Reconstruction System
K202232 · PHX
Biomet Manufacturing Corp
Orthopedic · 196d
Cleared Feb 19, 2021
CORE E3 Suction/irrigator
K202303 · GCJ
Conmed Corporation
General & Plastic Surgery · 189d
Cleared Feb 19, 2021
SPiN Vision Video Bronchoscope System
K202346 · EOQ
Veran Medical Technologies, Inc.
Ear, Nose, Throat · 185d
Cleared Feb 19, 2021
Born PT-LIF Cage HA
K202380 · MAX
Spineworxx AG
Orthopedic · 183d
Cleared Feb 19, 2021
MiniLoad Syringe
K202432 · FMF
Ocuject, LLC
General Hospital · 178d
Cleared Feb 19, 2021
ClearCap Distal Attachment
K202616 · OCX
Finemedix Co., Ltd.
Gastroenterology & Urology · 163d
Cleared Feb 19, 2021
X-ray Flat Panel Detectors/CareView 3600RF
K202995 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 141d
Cleared Feb 19, 2021
Inbrace Orthodontic System
K203442 · PNN
Swift Health Systems, Inc.
Dental · 88d
Cleared Feb 19, 2021
Advanced Dental Appliance
K203462 · LRK
Dasoft Partners
Dental · 87d
Cleared Feb 19, 2021
emField
K203488 · IPF
Zimmer Medizinsysteme GmbH
Physical Medicine · 84d
Cleared Feb 19, 2021
Eustachi Ear Pressure Relief Device
K203754 · MJV
Exercore, LLC
Ear, Nose, Throat · 58d
Cleared Feb 19, 2021
Duo Expandable Interbody Fusion System
K210155 · MAX
Spineology, Inc.
Orthopedic · 29d
Cleared Feb 19, 2021
DELTA XTEND Reverse Shoulder System
K210167 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Feb 19, 2021
A.L.P.S. Clavicle Plating System
K210192 · HRS
Biomet, Inc.
Orthopedic · 25d
Cleared CT Feb 18, 2021
Clue Birth Control
K193330 · PYT
Biowink GmbH
Obstetrics & Gynecology · 444d
Cleared Feb 18, 2021
3D Accuitomo 150N
K201378 · OAS
J. Morita USA, Inc.
Radiology · 268d
Cleared Feb 18, 2021
Demetra Analytics Toolkit
K201408 · PSN
Barco N.V.
General & Plastic Surgery · 266d
Cleared Feb 18, 2021
BEGO SEMADOS Tr 58350
K201412 · KCT
Bego Implant Systems GmbH & Co. KG
General Hospital · 266d
Cleared Feb 18, 2021
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
K201720 · DQX
Beijing Bywave Sensing Medical...
Cardiovascular · 240d
Cleared Feb 18, 2021
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
K201863 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 227d