Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
43585–43608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2012
AIMAGO EASYLDI MICROCIRCULATION CAMERA
K121429 · DPT
Aimago SA
Cardiovascular · 88d
Cleared Aug 10, 2012
MULTIX FUSION
K121513 · KPR
Siemens Medical Solution
Radiology · 81d
Cleared Aug 10, 2012
COMFORT EZ
K121632 · FMI
Simple Diagnostics, Inc.
General Hospital · 67d
Cleared Aug 10, 2012
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MJN
MicroVention, Inc.
Cardiovascular · 53d
Cleared Aug 10, 2012
IMRIS ONCOLOGY PACKAGE
K121997 · LNH
Imris, Inc.
Radiology · 32d
Cleared Aug 09, 2012
XENX
K113692 · OCY
Xenolith Medical
Gastroenterology & Urology · 238d
Cleared Aug 09, 2012
ESPIN
K120553 · HRX
Nlt Spine, Ltd.
Orthopedic · 168d
Cleared Aug 09, 2012
PICASSO MIS SPINAL FIXATION SYSTEM
K120714 · NKB
Accel Spine
Orthopedic · 154d
Cleared Aug 09, 2012
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
K120781 · DQY
Fuji Systems Corp.
Cardiovascular · 147d
Cleared Aug 09, 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · KWP
Accel Spine
Orthopedic · 118d
Cleared Aug 09, 2012
CRAWFORD BIOCANALICULUS INTUBATION
K121142 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 115d
Cleared Aug 09, 2012
PROFEMUR Z REVISION HIP STEM
K121221 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 108d
Cleared Aug 09, 2012
INSIGNIA
K121524 · DYW
Ormco Corp.
Dental · 78d
Cleared Aug 08, 2012
CONICAL CONNECTION IMPLANTS
K112162 · DZE
Mis Implants Technologies , Ltd.
Dental · 378d
Cleared Aug 08, 2012
KERATOR
K112787 · NHA
Kj Meditech Co., Ltd.
Dental · 317d
Cleared Aug 08, 2012
KENT CAMERA
K113507 · MUD
Kent Imaging, Inc.
Cardiovascular · 254d
Cleared Aug 08, 2012
FLASHPAK
K113776 · FRG
Symmetry Medical
General Hospital · 230d
Cleared Aug 08, 2012
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
K113820 · FRO
Novabay Pharmaceuticals
General & Plastic Surgery · 225d
Cleared Aug 08, 2012
CONVEY GUIDING CATHETER
K120585 · DQY
Pendracare International, B.V.
Cardiovascular · 163d
Cleared Aug 08, 2012
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
K121102 · GXN
Osteosymbionics, LLC
Neurology · 119d
Cleared Aug 08, 2012
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
K121168 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 113d
Cleared Aug 08, 2012
REFORM PEDICLE SCREW SYSTEM
K121172 · MNI
Spinal USA
Orthopedic · 113d
Cleared Aug 08, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K121839 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 47d
Cleared Aug 07, 2012
NAUTILUS SPINAL SYSTEM
K111953 · NKB
Life Spine
Orthopedic · 393d