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
79153–79176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2001
COPAN VIRAL TRANSYSTEM
K001780 · JSM
Copan Diagnostics, Inc.
Microbiology · 413d
Cleared Jul 31, 2001
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
K003285 · IYE
Brainlab AG
Radiology · 285d
Cleared Jul 31, 2001
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
K003580 · FFX
Unisensor AG
Gastroenterology & Urology · 253d
Cleared Jul 31, 2001
R STENT BILIARY ENDOPROSTHESIS
K010107 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 200d
Cleared Jul 31, 2001
SUREVUE URINE HCG
K010522 · JHI
Sa Scientific, Inc.
Toxicology · 159d
Cleared Jul 31, 2001
PREVISION CHEM
K010541 · EMA
Heraeus Kulzer, Inc.
Dental · 158d
Cleared Jul 31, 2001
METHADONE MICROPLATE EIA URINE APPLICATION
K011131 · DJR
Cozart Bioscience , Ltd.
Toxicology · 109d
Cleared Jul 31, 2001
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K011354 · HRS
Dj Orthopedics, LLC
Orthopedic · 89d
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 31, 2001
RESORBABLE BONE PINS
K011522 · HTY
Biomet, Inc.
Orthopedic · 75d
Cleared Jul 31, 2001
QCU ANALYTICAL SOFTWARE PACKAGE
K011582 · LLZ
Medis Medical Imaging Systems BV
Radiology · 69d
Cleared Jul 31, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
K011658 · JIX
Rochdiag
Chemistry · 63d
Cleared Jul 31, 2001
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP...
K011672 · LAF
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 31, 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST...
K011673 · DKZ
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 31, 2001
BISTITE II DC
K011685 · EMA
Tokuyama America, Inc.
Dental · 61d
Cleared Jul 31, 2001
ZOLL M SERIES IBP OPERATION
K011865 · DSK
Zoll Medical Corp
Cardiovascular · 47d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900 · CFR
Jas Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 31, 2001
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K011995 · LYY
Quality Latex Products Malaysia Sdn Bhd
General Hospital · 35d
Cleared Jul 31, 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
K012099 · LLZ
Totoku Electric Co., Ltd.
Radiology · 26d
Cleared Jul 31, 2001
PASS SPINAL SYSTEM
K012175 · MNI
Encore Orthopedics, Inc.
Orthopedic · 19d
Cleared Jul 31, 2001
EFILM WORKSTATION
K012211 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Jul 31, 2001
SCALPFIX CLIP SYSTEM
K012219 · HBO
Aesculap, Inc.
General & Plastic Surgery · 15d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · JWH
Exactech, Inc.
Orthopedic · 13d
Cleared Jul 30, 2001
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
K010734 · MLK
Branan Medical Corp.
Chemistry · 140d