FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78385–78408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 22, 2001
JP CAST 50
K011330 · EJT
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Jun 22, 2001
JP CAST 40
K011331 · EJT
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Jun 22, 2001
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
K011435 · KPI
Hmt, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 22, 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS...
K011584 · GZB
Medtronic Vascular
Neurology · 30d
Cleared Jun 22, 2001
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
K011612 · FQH
Hydrocision, Inc.
General Hospital · 28d
Cleared Jun 22, 2001
THE AUTOTAC SYSTEM
K011675 · DZL
BioHorizons Implant Systems, Inc.
Dental · 23d
Cleared Jun 22, 2001
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG...
K011677 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 23d
Cleared Jun 22, 2001
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
K011701 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 21d
Cleared Jun 22, 2001
STRYKER T4 HYTREL (R) TOGAS
K011755 · LYU
Stryker Corp.
General Hospital · 16d