FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
10753–10776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2023
Endo SmartCap
K223040 · FAJ
Medivators, Inc.
Gastroenterology & Urology · 153d
Cleared Mar 01, 2023
Galaxy System
K223144 · EOQ
Noah Medical Corp.
Ear, Nose, Throat · 148d
Cleared Mar 01, 2023
32HQ713D
K223423 · PGY
Lg Electronics.Inc
Radiology · 107d
Cleared Mar 01, 2023
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120,...
K230283 · DYB
Abbott Medical
Cardiovascular · 28d
Cleared Mar 01, 2023
Alma Harmony
K230308 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 26d
Cleared Feb 28, 2023
SpectraWAVE Imaging System
K221257 · NQQ
Spectrawave, Inc.
Cardiovascular · 302d
Cleared Feb 28, 2023
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova®...
K221641 · FRC
Terragene S.A.
General Hospital · 267d
Cleared Feb 28, 2023
U2 Total Knee System-PF+
K221705 · MBH
United Orthopedic Corporation
Orthopedic · 260d
Cleared Feb 28, 2023
AccuICAS
K221711 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 260d
Cleared Feb 28, 2023
HARMONIC 700 Shears
K221790 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 252d
Cleared Feb 28, 2023
EXPLORER AIR® II
K222240 · IZI
Surgvision GmbH
General & Plastic Surgery · 217d
Cleared Feb 28, 2023
PuraStat
K222481 · QAU
3-D Matrix, Inc.
General & Plastic Surgery · 195d
Cleared Feb 28, 2023
Mobility Scooter (Models: W3431Q, W3431R)
K222507 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 194d
Cleared Feb 28, 2023
8X-10-6XXX Camera Head
K223116 · GCJ
Santa Barbara Imaging Systems
General & Plastic Surgery · 148d
Cleared Feb 28, 2023
SurBlate Ablation System
K223272 · NEY
Mima-Pro Scientific, Inc.
General & Plastic Surgery · 127d
Cleared Feb 28, 2023
REVCON (TM) Screw System
K223392 · HWC
Voom Medical Devices, Inc.
Orthopedic · 112d
Cleared Feb 28, 2023
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06...
K223618 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 85d
Cleared Feb 28, 2023
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
K230038 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 53d
Cleared Feb 28, 2023
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System
K230245 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Feb 28, 2023
VIOLA
K230248 · DXC
Vascular Graft Solutions, Ltd.
Cardiovascular · 29d
Cleared Feb 27, 2023
Idylla MSI Test
K211181 · PZJ
Biocartis NV
Pathology · 678d
Cleared Feb 27, 2023
Milli Vaginal Dilator
K220035 · HDX
Materna Medical
Obstetrics & Gynecology · 418d
Cleared Feb 27, 2023
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
K222173 · OCX
Saneso, Inc.
Gastroenterology & Urology · 221d
Cleared Feb 27, 2023
Ogmend® Implant Enhancement System
K223075 · QVI
Woven Orthopedic Technologies
Orthopedic · 150d