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
11593–11616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2023
Dyna Locking Trochanteric Nail™
K221084 · HSB
Innosys
Orthopedic · 324d
Cleared Mar 03, 2023
Aspira Pleural Drainage System
K212696 · DWM
Merit Medical Systems, Inc.
Anesthesiology · 555d
Cleared Mar 02, 2023
AccuFFRangio Plus
K230303 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 27d
Cleared Mar 02, 2023
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · MTD
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Mar 02, 2023
Disposable 4 Layers Surgical Face Mask
K230093 · FXX
Social Medical Supply, LLC
General Hospital · 49d
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
NEBA® Compact EEG2R Mobile Headset
K223628 · OMC
Neba Health, LLC
Neurology · 87d
Cleared Mar 02, 2023
Traumatic brain injury (TBI) test
K223602 · QAT
Abbott Laboratories
Immunology · 90d
Cleared Mar 02, 2023
Insulin Syringe
K223453 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 106d
Cleared Mar 02, 2023
Plasma Pen (Plasma MD)
K223440 · QVJ
Plasma Concepts
General & Plastic Surgery · 108d
Cleared Mar 02, 2023
Artix AX
K223436 · QEW
Inari Medical
Cardiovascular · 108d
Cleared Mar 02, 2023
Tenderfoot
K223352 · FMK
Accriva Diagnostics, Inc.
General & Plastic Surgery · 120d
Cleared Mar 02, 2023
1.5T 24E Posterior Array
K223203 · LNH
Shenzhen RF Tech Co., Ltd.
Radiology · 139d
Cleared Mar 02, 2023
Rapid NCCT Stroke
K222884 · QAS
Ischemaview, Inc.
Radiology · 161d
Cleared Mar 02, 2023
6F Wallaby Long Sheath
K222603 · DQY
Wallaby Medical, Inc.
Neurology · 185d
Cleared Mar 02, 2023
BoneView
K222176 · QBS
Gleamer
Radiology · 223d
Cleared Mar 02, 2023
ReWalk P6.0
K221696 · PHL
Re Walk Robotics , Ltd.
Neurology · 265d
Cleared Mar 02, 2023
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound...
K221340 · EOQ
Boston Scientific Corporation
Anesthesiology · 297d
Cleared Mar 01, 2023
Alma Harmony
K230308 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 26d
Cleared Mar 01, 2023
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120,...
K230283 · DYB
Abbott Medical
Cardiovascular · 28d
Cleared Mar 01, 2023
32HQ713D
K223423 · PGY
Lg Electronics.Inc
Radiology · 107d
Cleared Mar 01, 2023
Galaxy System
K223144 · EOQ
Noah Medical Corp.
Ear, Nose, Throat · 148d
Cleared Mar 01, 2023
Endo SmartCap
K223040 · FAJ
Medivators, Inc.
Gastroenterology & Urology · 153d
Cleared Mar 01, 2023
Advantis Platform
K222975 · LLZ
Advantis Medical Imaging Single...
Radiology · 154d