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
18865–18888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2020
MS Lide Implant Systems
K181477 · DZE
Hangzhou Minsheng Lide Medical...
Dental · 868d
Cleared Oct 20, 2020
Hexanium® ACIF
K193000 · OVE
Spinevision, S.A.S.
Orthopedic · 358d
Cleared Oct 20, 2020
AccelFix Spinal Fixation System
K200794 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 208d
Cleared Oct 20, 2020
WEGO-PDO Barbed Suture
K201139 · NEW
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 175d
Cleared Oct 20, 2020
SpineJack Expansion Kit
K202393 · NDN
Stryker Corporation
Orthopedic · 60d
Cleared Oct 20, 2020
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1...
K202756 · LPL
CooperVision, Inc.
Ophthalmic · 29d
Cleared Oct 19, 2020
Zavation IBF System
K200084 · MAX
Zavation Medical Products, LLC
Orthopedic · 278d
Cleared Oct 19, 2020
Transcutaneous Electronic Nerve Stimulator
K200237 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 269d
Cleared Oct 19, 2020
anti-bacterial bandage
K200821 · FRO
Planet (Suzhou) Medical Products Co.,...
General & Plastic Surgery · 203d
Cleared Oct 19, 2020
TAPESTRY Biointegrative Implant
K201572 · OWY
Embody, Inc.
Orthopedic · 130d
Cleared Oct 19, 2020
Single Use Rotatable and Repositionable Hemoclip
K201771 · PKL
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 112d
Cleared Oct 19, 2020
Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
K202100 · PLV
Neocis, Inc.
Dental · 82d
Cleared Oct 19, 2020
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
K202374 · PGY
Shenzhen Beacon Display Technology...
Radiology · 61d
Cleared Oct 19, 2020
CD Horizon Spinal System
K202771 · NKB
Medtronic
Orthopedic · 28d
Cleared Oct 16, 2020
Selectra 3D Outer Guiding Catheters
K193474 · DQY
Biotronik, Inc.
Cardiovascular · 305d
Cleared Oct 16, 2020
MUTARS Cemented Femoral Stems
K200045 · MEH
Implantcast GmbH
Orthopedic · 282d
Cleared Oct 16, 2020
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro®...
K200408 · MQL
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 240d
Cleared Oct 16, 2020
CellaVision DC-1, CellaVision DC-1 PPA
K200595 · JOY
CellaVision AB
Hematology · 224d
Cleared Oct 16, 2020
MINICONE Implant
K200906 · DZE
Medentika GmbH
Dental · 193d
Cleared Oct 16, 2020
Medline Smoke Evacuation Pencil
K201129 · GEI
Medline Industires, Inc.
General & Plastic Surgery · 171d
Cleared Oct 16, 2020
Finetest Lite Smart Blood Glucose Monitoring System
K201396 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 141d
Cleared Oct 16, 2020
Cerament Bone Void Filler
K201535 · MQV
Bonesupport AB
Orthopedic · 130d
Cleared Oct 16, 2020
A View LCS
K201710 · LLZ
Coreline Soft Co., Ltd.
Radiology · 115d
Cleared Oct 16, 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K201803 · HTY
OSSIO , Ltd.
Orthopedic · 108d