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
24673–24696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2018
GM Implant Tubes, Length Cutting Gauge
K172533 · JAQ
Varian Medical Systems, Inc.
Radiology · 426d
Cleared Oct 22, 2018
TD-1035 Thermometer
K172733 · FLL
Taidoc Technology Corporation
General Hospital · 406d
Cleared Oct 22, 2018
ANTHEM Fracture System
K180554 · HRS
Globus Medical, Inc.
Orthopedic · 235d
Cleared Oct 22, 2018
PIP Fix
K181192 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 171d
Cleared Oct 22, 2018
Comarch e-Care Platform
K181248 · DRG
Comarch Healthcare SA
Cardiovascular · 165d
Cleared Oct 22, 2018
Quadra P
K181254 · LZO
Medacta International S.A.
Orthopedic · 164d
Cleared Oct 22, 2018
Nutrifill
K181566 · MRC
Contamac, Ltd.
Ophthalmic · 130d
Cleared Oct 22, 2018
Sonendo Material A
K181922 · KIF
Sonendo, Inc.
Dental · 96d
Cleared Oct 20, 2018
ImPACT
K181223 · POM
Impact Applications, Inc.
Neurology · 165d
Cleared Oct 19, 2018
Straumann cerabone
K173594 · NPM
Institut Straumann AG
Dental · 332d
Cleared Oct 19, 2018
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by...
K180202 · DBL
Immuno Concepts, N.A. , Ltd.
Immunology · 268d
Cleared Oct 19, 2018
AVELLE Negative Pressure Wound Therapy System
K180205 · OMP
Convatec Limited
General & Plastic Surgery · 268d
Cleared Oct 19, 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
K180213 · HRS
Synthes USA Products, LLC
Orthopedic · 267d
Cleared Oct 19, 2018
EchoS
K180516 · MUA
Echolight S.P.A
Radiology · 234d
Cleared Oct 19, 2018
MAGNETOM Vida
K181433 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 19, 2018
Stable-C Interbody System
K181621 · OVE
Nexus Spine, LLC
Orthopedic · 121d
Cleared Oct 19, 2018
ICONN Revolution Knotless Suture Anchor
K182264 · MBI
Iconn Orthopedics, LLC
Orthopedic · 59d
Cleared Oct 19, 2018
Vantage Orian 1.5T, MRT-1550, V4.5
K182282 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 19, 2018
Vivid S60N, Vivid S70N
K182450 · IYN
GE Medical Systems Ultrasound and...
Radiology · 42d
Cleared Oct 19, 2018
UroNav (Version 3.0)
K182561 · LLZ
Invivo Corporation
Radiology · 31d
Cleared Oct 19, 2018
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure...
K182586 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 19, 2018
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K182590 · MOS
Ge Healthcare
Radiology · 29d
Cleared Oct 19, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
K182644 · DQK
Abbott
Cardiovascular · 25d
Cleared Oct 19, 2018
Paragonix SherpaPak Cardiac Transport System
K182735 · MSB
Paragonix Technologies
Gastroenterology & Urology · 21d