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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78889–78912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2001
QUELL DESENSITIZER
K010957 · LBH
Jeneric/Pentron, Inc.
Dental · 87d
Cleared Jun 25, 2001
BRACHYSEED PD-103 MODELS #PD1
K011119 · KXK
Draximage, Inc.
Radiology · 74d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · JFJ
Roche Diagnostics Corp.
Chemistry · 91d
Cleared Jun 25, 2001
ICS MEDICAL CHARTR OAE WITH TYMP
K011181 · EWO
Ics Medical Corp.
Ear, Nose, Throat · 68d
Cleared Jun 25, 2001
PORTABELL, MODEL 4200
K011222 · EIA
Bell Dental Products, LLC
Dental · 66d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · JIX
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 25, 2001
ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
K011245 · DZE
Sulzer Dental, Inc.
Dental · 63d
Cleared Jun 25, 2001
PHASE II GBM IGG ANTIBODY EIA TEST
K011348 · MVJ
Scimedx Corp.
Immunology · 54d
Cleared Jun 25, 2001
MICRODOSE CATH, MODELS 90121-201, -202, -203
K011383 · ETD
Durect Corp.
Ear, Nose, Throat · 49d
Cleared Jun 25, 2001
IL TEST PROS
K011424 · GGP
Instrumentation Laboratory CO
Hematology · 47d
Cleared Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · CIX
Olympus America, Inc.
Chemistry · 21d
Cleared Jun 22, 2001
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 318d
Cleared Jun 22, 2001
MAR COR SERVICES SEMPER PURE RO MACHINE
K003877 · FIP
Mar Cor Services, Inc.
Gastroenterology & Urology · 189d
Cleared Jun 22, 2001
CHESS HAND SURGERY SYSTEM
K010184 · MDM
Canica Design, Inc.
General & Plastic Surgery · 154d
Cleared Jun 22, 2001
POWDER FREE NITRILE EXAMINATION GLOVES
K010233 · LZA
P.T. Healthcare Glovindo
General Hospital · 149d
Cleared Jun 22, 2001
ML BLADE, MODEL ML7030
K010872 · HNO
Med-Logics, Inc.
Ophthalmic · 91d
Cleared Jun 22, 2001
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K010920 · HEL
Medical Cables, Inc.
Obstetrics & Gynecology · 87d
Cleared Jun 22, 2001
THE NIMBLE ROCKET POWERED WHEELCHAIR
K010941 · ITI
Nimble, Inc.
Physical Medicine · 85d
Cleared Jun 22, 2001
AMS SLING FIXATION SYSTEM
K010990 · GAW
American Medical Systems, Inc.
General & Plastic Surgery · 80d
Cleared Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 2001
TAUT BALLOON CATHETER, MODEL 50640
K011018 · GCA
Taut, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 2001
NEUROGEN NERVE GUIDE
K011168 · JXI
Integra Lifesciences Corp.
Neurology · 66d
Cleared Jun 22, 2001
AUTOMATED CORE BIOPSY DEVICE
K011270 · FCG
Promex, Inc.
Gastroenterology & Urology · 57d
Cleared Jun 22, 2001
LUTE VLC
K011309 · EBF
First Scientific Limited
Dental · 53d