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
43009–43032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K113783 · LON
bioMerieux, Inc.
Microbiology · 229d
Cleared Aug 07, 2012
SUCTION LIPOLASTY ACCESSORIES
K113795 · QPB
Norman M. Black Iii
General & Plastic Surgery · 228d
Cleared Aug 07, 2012
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · MDB
Becton, Dickinson and Company
Microbiology · 127d
Cleared Aug 07, 2012
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
K121059 · IMG
Zimmer Medizinsystems GmbH
Physical Medicine · 123d
Cleared Aug 07, 2012
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
K121393 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Aug 07, 2012
IDS-ISYS IGF-I CALIBRATION VERIFIERS
K122141 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 19d
Cleared Aug 06, 2012
ET II BIO-SA FIXTURE SYSTEM
K112532 · DZE
Hiossen, Inc.
Dental · 341d
Cleared Aug 06, 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4...
K113437 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 259d
Cleared Aug 06, 2012
HEART SYNC PEDIATRIC PHYSIO AED PAD
K120536 · MKJ
Heart Sync, Inc.
Cardiovascular · 166d
Cleared Aug 06, 2012
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K121158 · NLH
Sterilmed, Inc.
Cardiovascular · 112d
Cleared Aug 06, 2012
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
K121698 · EJR
Dentsply International, Inc.
Dental · 59d
Cleared Aug 06, 2012
G-SCAN BRIO
K122006 · LNH
Esaote, S.P.A.
Radiology · 28d
Cleared Aug 03, 2012
IDENTIFY
K112692 · IYE
Humediq GmbH
Radiology · 323d
Cleared Aug 03, 2012
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
K113077 · NBW
Taidoc Technology Corporation
Chemistry · 291d