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
72289–72312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2003
Z-BOX
K030764 · HAW
Z-Kat, Inc.
Neurology · 44d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779 · DQY
Medtronic Vascular
Cardiovascular · 44d
Cleared Apr 24, 2003
VERITAS COLLAGEN MATRIX
K030879 · OXE
Synovis Surgical Innovations
General & Plastic Surgery · 35d
Cleared Apr 24, 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · LWJ
Plus Orthopedics
Orthopedic · 27d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 24, 2003
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14,...
K030984 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 27d
Cleared Apr 24, 2003
EDWARDS INTRODUCER SHEATH
K031087 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 17d
Cleared Apr 24, 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · KWP
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD...
K023256 · NBW
Abbott Laboratories
Chemistry · 205d
Cleared Apr 23, 2003
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
K023454 · CCK
Datex-Ohmeda
Anesthesiology · 190d
Cleared Apr 23, 2003
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K024342 · IXW
Daito Co., Ltd.
Radiology · 117d
Cleared Apr 23, 2003
F1 DIODE LASER SYSTEM
K030235 · GEX
Opus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Apr 23, 2003
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
K030243 · DZE
Imtec Corp.
Dental · 90d
Cleared Apr 23, 2003
AXCEL SURGICAL LIGHT
K030906 · FSY
Alm
General & Plastic Surgery · 30d
Cleared Apr 23, 2003
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090,...
K030937 · CAZ
Arrow International, Inc.
Anesthesiology · 29d
Cleared Apr 23, 2003
VTI 20 MHZ GATED DOPPLER
K031091 · DPW
Vascular Technology Incorporated
Cardiovascular · 16d
Cleared Apr 22, 2003
VITALCARE URETHRAL CATHETER
K021938 · GBM
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 22, 2003
VITALCARE FOLEY CATHETER
K021939 · EZL
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Apr 22, 2003
NOVAVISION, MODEL 2.0
K023623 · HPT
Novavision, Inc.
Neurology · 175d
Cleared Apr 22, 2003
INSORB ABSORBABLE STAPLES, MODEL SP-B20
K024117 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 130d
Cleared Apr 22, 2003
WORRY-REMOVER IRRIGATOR
K030056 · HED
Corisen Group, Ltd.
Obstetrics & Gynecology · 106d
Cleared Apr 22, 2003
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K030129 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 98d
Cleared Apr 22, 2003
BABY POD
K030283 · FPP
Prism Enterprises, Inc.
General Hospital · 85d