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
16825–16848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2021
AortaSTAT Occlusion Device
K210602 · MJN
Renalpro Medical, Inc.
Cardiovascular · 130d
Cleared Jul 09, 2021
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
K210607 · LOD
Heraeus Medical GmbH
Orthopedic · 130d
Cleared Jul 09, 2021
HM70 EVO Diagnostic Ultrasound System
K210713 · IYN
Samsung Medison Co., Ltd.
Radiology · 121d
Cleared Jul 09, 2021
Medical PVC Examination Gloves
K210821 · LYZ
Jiangxi Hongda Medical Equipment...
General Hospital · 112d
Cleared Jul 09, 2021
Grosz Play Feel
K211088 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 88d
Cleared Jul 09, 2021
BTL-899 FP
K211107 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 86d
Cleared Jul 09, 2021
Monarch Platform
K211493 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 09, 2021
PRIMO S
K211542 · MQB
A.T.S. Applicazione Tecnologie...
Radiology · 51d
Cleared Jul 09, 2021
Extreme X8
K211574 · ITI
Magic Mobility
Physical Medicine · 49d
Cleared Jul 08, 2021
Nebulizer Kit
K192971 · CAF
Excellentcare Medical (Huizhou) , Ltd.
Anesthesiology · 624d
Cleared Jul 08, 2021
SensiTox C. difficile Toxin Test
K193490 · LLH
First Light Diagnostics, Inc.
Microbiology · 569d
Cleared Jul 08, 2021
PRE-SURE
K201835 · LLZ
Lazarus 3D, Inc.
Radiology · 371d
Cleared Jul 08, 2021
TruAbutment DS, TruBase
K202579 · NHA
Truabutment, Inc.
Dental · 303d
Cleared Jul 08, 2021
END 200 Endoscopic Tubeset
K202922 · FCX
Palliare , Ltd.
Gastroenterology & Urology · 282d
Cleared Jul 08, 2021
Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030)
K203148 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 259d
Cleared Jul 08, 2021
BioWave BioWraps
K203158 · GXY
Biowave Corporation
Neurology · 259d
Cleared Jul 08, 2021
iSR'obot Mona Lisa 1.0
K203659 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 205d
Cleared Jul 08, 2021
SurroundScope System
K210104 · HET
270surgical , Ltd.
Obstetrics & Gynecology · 175d
Cleared Jul 08, 2021
Disposable Surgical Mask
K210267 · FXX
Xiamen Eagledon Pharmaceutical Co., Ltd.
General Hospital · 157d
Cleared Jul 08, 2021
Medical surgical mask
K210380 · FXX
Shantou T&K Medical Equipment Factory...
General Hospital · 149d
Cleared Jul 08, 2021
Ultra SEP
K210945 · KLE
Reliance Orthodontic Products, Inc.
Dental · 100d
Cleared Jul 08, 2021
Straumann RidgeFit Implants
K211052 · DZE
Institut Straumann AG
Dental · 90d
Cleared Jul 08, 2021
Nerve and Muscle Stimulator
K211094 · IPF
Shenzhen Xft Medical Limited
Physical Medicine · 87d
Cleared Jul 08, 2021
StealthStation Spinous Process Clamps
K211442 · OLO
Medtronic Navigation
Orthopedic · 59d