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
69937–69960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2003
ARTHROCARE ENT PLASMA WANDS
K033257 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Oct 29, 2003
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
K023000 · IPF
Home Care Technology Co., Ltd.
Physical Medicine · 415d
Cleared Oct 29, 2003
AMSURE FOLEY CATHETER
K030120 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 289d
Cleared Oct 29, 2003
STICK FLOW
K031341 · EBF
Stick Tech , Ltd.
Dental · 184d
Cleared Oct 29, 2003
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH...
K032024 · LZA
Shen Wei (Usa), Inc.
General Hospital · 121d
Cleared Oct 29, 2003
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 114d
Cleared Oct 29, 2003
PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
K032119 · KCT
Paragon Medical, Inc.
General Hospital · 112d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Oct 29, 2003
GIVEN DIAGNOSTIC SYSTEM
K032405 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 86d
Cleared Oct 29, 2003
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442 · MQN
KLS-Martin L.P.
Dental · 82d
Cleared Oct 29, 2003
MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
K032599 · GEX
Medical Laser Technologies, LLC
General & Plastic Surgery · 65d
Cleared Oct 29, 2003
XTRAK SUPPORT CATHETER
K032660 · DQY
Xtrak Medical, Inc.
Cardiovascular · 62d
Cleared Oct 29, 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · LLZ
Vital Images, Inc.
Radiology · 54d
Cleared Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
K032962 · FOZ
Arrow Intl., Inc.
General Hospital · 36d
Cleared Oct 29, 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · MQN
Synthes (Usa)
Dental · 30d
Cleared Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078 · MSX
Datex-Ohmeda
Cardiovascular · 30d
Cleared Oct 29, 2003
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
K033088 · LLZ
Sectra AB
Radiology · 30d
Cleared Oct 29, 2003
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
K033126 · LIL
Behavioral Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 29, 2003
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
K033140 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 29d
Cleared Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 29, 2003
SUPEROPEN 0.23T, MODEL NAM-P023A
K033315 · LNH
Neusoft Digital Medical Systems Co.,...
Radiology · 14d
Cleared Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · JAK
Philips Medical Systems, Inc.
Radiology · 13d
Cleared Oct 28, 2003
ORTRAUTEK ORTHOGNATHIC SYSTEM
K031989 · JEY
Tekka
Dental · 123d
Cleared Oct 28, 2003
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d