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
74377–74400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2002
CERALOY
K021971 · EJH
Neirynck & Vogt NV
Dental · 45d
Cleared Aug 01, 2002
ESCAPE CONTROL MODULE
K021995 · ITI
Specialty Drives Technologies, Inc.
Physical Medicine · 44d
Cleared Aug 01, 2002
PERIFIX CATHETER CONNECTOR
K022019 · BSO
B.Braun Medical, Inc.
Anesthesiology · 42d
Cleared Aug 01, 2002
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
K022024 · LZA
Best Manufacturing Company
General Hospital · 42d
Cleared Aug 01, 2002
XIA SPINAL SYSTEM
K022160 · MNI
Howmedica Osteonics
Orthopedic · 29d
Cleared Aug 01, 2002
STRYKER T4 URETHANE HOOD
K022162 · FYA
Stryker Instruments
General Hospital · 29d
Cleared Aug 01, 2002
ENVOY
K022168 · DQA
Mennen Medical , Ltd.
Anesthesiology · 29d
Cleared Aug 01, 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
K022193 · DQA
Ge Medical Systems Information...
Anesthesiology · 27d
Cleared Aug 01, 2002
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · MEA
Abbott Laboratories
General Hospital · 27d
Cleared Aug 01, 2002
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
K022232 · JJX
Cliniqa Corporation
Chemistry · 22d
Cleared Aug 01, 2002
ADVANTAGE WINDOWS X-RAY/MR FUSION
K022310 · LLZ
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Jul 31, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012688 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 351d
Cleared Jul 31, 2002
POLAR WAND
K021387 · GEH
Chek-Med Systems
General & Plastic Surgery · 90d
Cleared Jul 30, 2002
PANAG
K011891 · GZJ
Panag International
Neurology · 407d
Cleared Jul 30, 2002
TRACH VOX
K013728 · JOH
Engineered Medical Systems
Anesthesiology · 263d
Cleared Jul 30, 2002
WU'S 4-WHEELED NEO SCOOTER, WT-L4
K013763 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 259d
Cleared Jul 30, 2002
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070 · LPH
Zimmer, Inc.
Orthopedic · 232d
Cleared Jul 30, 2002
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
K020042 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 204d
Cleared Jul 30, 2002
SELICOR, MODELS A100 & D100
K020227 · IMJ
Selicor, Inc.
Physical Medicine · 189d
Cleared Jul 30, 2002
HI-OX
K020665 · CBP
Sensor Medics Corp.
Anesthesiology · 151d
Cleared Jul 30, 2002
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
K021041 · LYY
W.A. Rubbermate Co., Ltd.
General Hospital · 120d
Cleared Jul 30, 2002
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
K021231 · MMW
Matritech, Inc.
Immunology · 103d
Cleared Jul 30, 2002
TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT,...
K021264 · ITI
Motion Concepts
Physical Medicine · 99d
Cleared Jul 30, 2002
TTECH MODEL 200E + TENS DEVICE
K021436 · GZJ
Theratech, Inc.
Neurology · 85d