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
19945–19968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2020
SleepRight ProRx Custom Dental Guard
K193577 · OBR
Splintek, Inc.
Dental · 161d
Cleared Jun 01, 2020
Jimushi Sterile Urethral Catheter for single use
K200134 · GBM
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 132d
Cleared Jun 01, 2020
3MTM AttestTM Rapid 5 Steam-Plus Test Pack
K200536 · FRC
3M Complany
General Hospital · 90d
Cleared Jun 01, 2020
Skeletal Dynamics Forearm Plating System
K200538 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared Jun 01, 2020
BRAINSTREAM Disposable Deep Cup EEG Electrodes
K200540 · GXY
Conmed Corporation
Neurology · 90d
Cleared Jun 01, 2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs...
K200897 · KGO
Hartalega Sdn Bhd
General Hospital · 59d
Cleared May 29, 2020
Automatic Digital Blood Pressure Monitor
K190982 · DXN
Xiamen Ants Bro Technology Co., Ltd.
Cardiovascular · 410d
Cleared May 29, 2020
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04,...
K191334 · IPL
Matia Robotics (Us), Inc.
Physical Medicine · 378d
Cleared May 29, 2020
Dental Zirconia Blocks
K192262 · EIH
De Corematrix Co., Ltd.
Dental · 282d
Cleared May 29, 2020
Crownjun Nylon Suture
K192420 · GAR
Kono Seisakusho Co., Ltd.
General & Plastic Surgery · 268d
Cleared May 29, 2020
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
K193495 · PNO
Transit Scientific
Cardiovascular · 164d
Cleared May 29, 2020
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
K193602 · KXK
Lv Liberty Vision Corporation
Radiology · 158d
Cleared May 29, 2020
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
K200002 · OVD
4Web, Inc.
Orthopedic · 148d
Cleared May 29, 2020
KONG-TL VBR System, KONG-C VBR System
K200235 · MQP
Icotec AG
Orthopedic · 120d
Cleared May 29, 2020
ADVIA Centaur Vitamin D Total (VitD)
K200509 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared May 29, 2020
ROSA ONE Brain application
K200511 · HAW
Medtech S.A
Neurology · 88d
Cleared May 29, 2020
Aspire Mechanical Aspirator G
K200629 · FMF
Control Medical Technology
General Hospital · 80d
Cleared May 29, 2020
Idys ALIF ZP 3DTi
K200920 · MAX
Clariance, Sas
Orthopedic · 53d
Cleared May 29, 2020
CFP-3131, CFP-2222
K201172 · OWB
Mx Imaging, Inc.
Radiology · 28d
Cleared May 29, 2020
iLab Polaris Multi-Modality Guidance System
K201178 · DQK
Boston Scientific
Cardiovascular · 28d
Cleared May 29, 2020
Stealthstation S8 Spine Software v1.3.0
K201189 · OLO
Medtronic Navigation, Inc.
Orthopedic · 28d
Cleared May 28, 2020
Brainomix 360 e-CTA
K192692 · LLZ
Brainomix Limited
Radiology · 245d
Cleared May 28, 2020
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
K192981 · QEW
Penumbra, Inc.
Cardiovascular · 217d
Cleared May 28, 2020
REVOLVE ENVI 600 Advanced Adipose System
K193539 · MUU
Lifecell Corporation
General & Plastic Surgery · 160d