Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
75505–75528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 30, 2002
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL...
K021442 · BTM
Oemedic International, Inc.
Anesthesiology · 85d
Cleared Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K021482 · NIY
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Jul 30, 2002
CHROLOY
K021969 · EJH
Neirynck & Vogt NV
Dental · 43d
Cleared Jul 30, 2002
QUINCKE SPINAL NEEDLE
K022029 · BSP
Epimed International, Inc.
Anesthesiology · 39d
Cleared Jul 30, 2002
PROVOX FREEHANDS HME, MODEL 7710
K022125 · EWL
Atos Medical AB
Ear, Nose, Throat · 29d
Cleared Jul 30, 2002
VERDICT-II
K022141 · DJC
Medtox Diagnostics, Inc.
Toxicology · 28d
Cleared Jul 30, 2002
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K022296 · GEI
Neothermia Corp.
General & Plastic Surgery · 14d