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
21097–21120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · JWY
Liofilchem S. R. L.
Microbiology · 63d
Cleared Oct 31, 2019
087 Balloon Guide Catheter System
K192525 · DQY
Q'Apel Medical, LLC
Neurology · 48d
Cleared Oct 31, 2019
VisionX 2.4
K192743 · LLZ
Durr Dental SE
Radiology · 31d
Cleared Oct 31, 2019
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
K192867 · GEI
Bovie Medical Corporation Dba Apyx...
General & Plastic Surgery · 24d
Cleared Oct 31, 2019
ADH19
K192961 · KLE
3M Deutschland GmbH
Dental · 9d
Cleared Oct 30, 2019
EZE SIT Valvulotome
K190267 · MGZ
Lemaitre Vascular
Cardiovascular · 264d
Cleared Oct 30, 2019
Arthrex Low Profile Screws
K190921 · HWC
Arthrex, Inc.
Orthopedic · 204d
Cleared Oct 30, 2019
IB3D ALIF
K191134 · MAX
Medicrea International SA
Orthopedic · 184d
Cleared Oct 30, 2019
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology...
K191170 · NLH
Innovative Health, LLC
Cardiovascular · 182d
Cleared Oct 30, 2019
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
K191264 · OQY
Ujenzi Charitable Trust
Obstetrics & Gynecology · 173d
Cleared Oct 30, 2019
Okami Medical LOBO Vascular Occlusion System
K192083 · KRD
Okami Medical
Cardiovascular · 89d
Cleared Oct 30, 2019
Treace Medical Concepts (TMC) Plating System
K192504 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 48d
Cleared Oct 30, 2019
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and...
K192775 · PJB
Stereotaxis, Inc.
Cardiovascular · 30d
Cleared Oct 30, 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
K192783 · DQX
Scientia Vascular, LLC
Neurology · 30d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2019
BRILLIANT COMPONEER
K191385 · EBF
Coltene/Whaledent AG
Dental · 159d
Cleared Oct 29, 2019
EmFace Device
K191855 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 111d
Cleared Oct 29, 2019
Compression Therapy Device Model LGT-2200SP
K191862 · IRP
Guangzhou Longest Science &...
Physical Medicine · 110d
Cleared Oct 29, 2019
MATRx Plus
K191925 · MNR
Zephyr Sleep Technologies
Dental · 103d
Cleared Oct 29, 2019
G21 SpaceFlex Hip
K192041 · MBB
G21, S.R.L.
Orthopedic · 90d
Cleared Oct 29, 2019
W Zirconia Implants
K192053 · DZE
Tav Medical , Ltd.
Dental · 90d
Cleared Oct 29, 2019
Game Ready GRPro 2.1 System
K192114 · IRP
Cool Systems, Inc. (Dba Game Ready)
Physical Medicine · 84d
Cleared Oct 29, 2019
Black Diamond Pedicle Screw System
K192121 · NKB
Osseus Fusion Systems
Orthopedic · 84d
Cleared Oct 29, 2019
Zimmer Biomet Universal Navigation System
K192133 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 83d