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
41881–41904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2012
Q-PLUS T+ IPL LASER SYSTEM
K123168 · GEX
Quanta System Spa
General & Plastic Surgery · 72d
Cleared Dec 20, 2012
g.HIamp
K123255 · GWL
G.Tec Medical Engineering GmbH
Neurology · 63d
Cleared Dec 20, 2012
TRUEBEAM
K123291 · IYE
Varian Medical Systems, Inc.
Radiology · 59d
Cleared Dec 20, 2012
HEALTHVIEW ECG MANAGER
K123466 · DQK
Lumedx
Cardiovascular · 41d
Cleared Dec 20, 2012
AEROPILOT
K123499 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 37d
Cleared Dec 20, 2012
SCENIUM
K123528 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Dec 20, 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · LLZ
Hologic, Inc.
Radiology · 34d
Cleared Dec 20, 2012
SYNGO, CT CARDIAC FUNCTION
K123585 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Dec 20, 2012
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF...
K123659 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Dec 19, 2012
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
K112644 · MQK
Lotus Bio, Ltd.
Obstetrics & Gynecology · 464d
Cleared Dec 19, 2012
IND ONE STEP OCCULT BLOOD (FOB) TEST
K113506 · KHE
Ind Diagnostics, Inc.
Hematology · 387d
Cleared Dec 19, 2012
HELIO
K120628 · IOR
Motion Composites
Physical Medicine · 293d
Cleared Dec 19, 2012
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
K120985 · BTR
Kimberly-Clark Corp.
Anesthesiology · 261d
Cleared Dec 19, 2012
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
K121369 · GZJ
Ibramed Equipamentos Medicos
Neurology · 226d
Cleared Dec 19, 2012
INTRAVASCULAR ADMINISTRATION SET
K121803 · FPA
Acta Medical, LLC
General Hospital · 183d
Cleared Dec 19, 2012
CERTUS 140 2.45GHZ ABLATION SYSTEM
K122217 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 147d
Cleared Dec 19, 2012
BASIXCONPAK ANALOG INFLATION SYRINGE
K122321 · MAV
Merit Medical Ireland, Ltd.
Cardiovascular · 140d
Cleared Dec 19, 2012
PMT TRUSCAN SURFACE ELECTRODE
K122376 · GXY
Pmt Corp.
Neurology · 135d
Cleared Dec 19, 2012
ONTEX AND OTHER PROPRIETARY NAMES
K122603 · HEB
Ontex Bvba
Obstetrics & Gynecology · 114d
Cleared Dec 19, 2012
MOBICATH TRANSSEPTAL NEEDLE
K122832 · DRC
Great Batch Medical
Cardiovascular · 93d
Cleared Dec 19, 2012
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
K122954 · MBI
Foundry Newcoxi, Inc.
Orthopedic · 85d
Cleared Dec 19, 2012
FINN CHAMBERS AQUA
K123184 · KXF
Smartpractice
General Hospital · 70d
Cleared Dec 19, 2012
OVS1 VIDEO SYSTEM
K123359 · FCW
Olive Medical Corp.
Gastroenterology & Urology · 49d
Cleared Dec 18, 2012
EVOLUTION 3E VENTILATOR
K113743 · CBK
Event Medical, Inc.
Anesthesiology · 364d