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
15961–15984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2021
Sterile Hypodermic Needles for Single Use
K211214 · FMI
Azur Medical Company, Inc.
General Hospital · 174d
Cleared Oct 14, 2021
Family of Venus RF Systems - Venus Freedom
K211461 · PBX
Venus Concept USA, Inc.
General & Plastic Surgery · 156d
Cleared Oct 14, 2021
Sterile Syringe With Safety Needle
K211753 · MEG
Jiangxi Hongda Medical Equipment...
General Hospital · 129d
Cleared Oct 14, 2021
Sapphire NC 24
K211807 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 125d
Cleared Oct 14, 2021
Nitrile Patient Examination Gloves
K211914 · LZA
Yingxiang Glove Products Co., Ltd.
General Hospital · 115d
Cleared Oct 14, 2021
Medical Protective Masks
K212205 · FXX
Qinhuangdao Taizhi Medical Technology...
General Hospital · 91d
Cleared Oct 14, 2021
StrokeSENS LVO
K212261 · QAS
Circle Neurovascular Imaging, Inc.
Radiology · 86d
Cleared Oct 14, 2021
SCORPION Portal Vein Access Set
K213002 · DYB
Argon Medical Devices
Cardiovascular · 24d
Cleared Oct 13, 2021
Video Endoscopy System, 3D Video Endoscopy System
K210116 · HET
Surgnova Healthcare Technologies...
Obstetrics & Gynecology · 267d
Cleared Oct 13, 2021
Proclean - Nitrile Powder Free Examination Gloves
K211374 · LZA
Dr.Boo Company Limited
General Hospital · 162d
Cleared Oct 13, 2021
SPRINT PNS System
K211801 · NHI
Spr Therapeutics, Inc.
Neurology · 125d
Cleared Oct 13, 2021
UltraCal XS
K211905 · KIF
Ultradent Products, Inc.
Dental · 114d
Cleared Oct 13, 2021
Medical Nitrile Examination Gloves
K212014 · LZA
Jiangxi Ronglai Medical Technology...
General Hospital · 107d
Cleared Oct 13, 2021
MiniLoad Syringe
K212544 · FMF
Ocuject, LLC
General Hospital · 62d
Cleared Oct 13, 2021
CoreLink Navigation Instruments
K212825 · OLO
Corelink, LLC
Orthopedic · 40d
Cleared Oct 13, 2021
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
K212908 · NRY
Neuravi, Ltd.
Neurology · 30d
Cleared Oct 12, 2021
Disposable Surgical Mask (Model: YYKZ-01)
K210845 · FXX
Jiaxing Amazing Travel-Ware Co., Ltd.
General Hospital · 204d
Cleared Oct 12, 2021
Nitrile examination gloves
K211927 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 112d
Cleared Oct 12, 2021
VBrain-OAR
K212116 · QKB
Vysioneer, Inc.
Radiology · 97d
Cleared Oct 12, 2021
BC Reflex Uni Knee System
K212307 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 81d
Cleared Oct 12, 2021
Correx Software
K212552 · KTT
Vilex, LLC
Orthopedic · 60d
Cleared Oct 12, 2021
Signature™ ONE System
K212560 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 60d
Cleared Oct 12, 2021
Idys-C ZP 3DTi
K212562 · OVE
Clariance, SA
Orthopedic · 60d
Cleared Oct 10, 2021
Child Face Mask
K201514 · OXZ
Shandong Shengquan New Material Co.,...
General Hospital · 489d