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
11017–11040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2023
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
K223902 · IYO
Echosens
Radiology · 64d
Cleared Mar 02, 2023
Disposable 4 Layers Surgical Face Mask
K230093 · FXX
Social Medical Supply, LLC
General Hospital · 49d
Cleared Mar 02, 2023
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · MTD
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Mar 02, 2023
AccuFFRangio Plus
K230303 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 27d
Cleared Mar 01, 2023
ProTrack Pigtail Wire
K213898 · DQX
Baylis Medical Company, Inc.
Cardiovascular · 442d
Cleared Mar 01, 2023
RSHOCK
K220014 · PBX
Swims America Corp
General & Plastic Surgery · 420d
Cleared Mar 01, 2023
Magnes-C Anterior Cervical Plate System
K221053 · KWQ
Fellowship of Orthopaedic...
Orthopedic · 324d
Cleared Mar 01, 2023
Xeleris V Processing and Review System
K221680 · LLZ
Ge Healthcare
Radiology · 265d
Cleared Mar 01, 2023
Multistage Balloon Dilatation Catheter
K222187 · KTI
Dongguan TT Medical, Inc.
Ear, Nose, Throat · 222d
Cleared Mar 01, 2023
Bigfoot Unity® Diabetes Management System
K222280 · QLG
Bigfoot Biomedical, Inc.
Chemistry · 215d
Cleared Mar 01, 2023
Advantis Platform
K222975 · LLZ
Advantis Medical Imaging Single...
Radiology · 154d
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