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
69145–69168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2004
STARDUST II, MODEL 1011176
K021845 · MNR
Respironics, Inc.
Anesthesiology · 715d
Cleared May 20, 2004
LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL...
K033899 · NFX
Lifestream Technologies, Inc.
Chemistry · 155d
Cleared May 20, 2004
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 100d
Cleared May 20, 2004
PROTEX STABILIZATION SYSTEM
K040442 · MNH
Globus Medical, Inc.
Orthopedic · 90d
Cleared May 20, 2004
SLIP UROLOGY CATHETER
K040519 · EZD
Percutaneous Systems, Inc.
Gastroenterology & Urology · 83d
Cleared May 20, 2004
SLIP UROLOGY INTRODUCER SHEATH
K040520 · KNY
Percutaneous Systems, Inc.
Gastroenterology & Urology · 83d
Cleared May 20, 2004
PORTA SOLDER 1090 W
K040524 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 80d
Cleared May 20, 2004
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
K040575 · CGJ
Phamatech, Inc.
Chemistry · 77d
Cleared May 20, 2004
COMBI SELF PROPELLED SHOWER COMMODE
K040677 · IOR
Kjaerulff Rehabilitation A/S
Physical Medicine · 66d
Cleared May 20, 2004
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K040829 · DSY
Vascutek, Ltd.
Cardiovascular · 50d
Cleared May 20, 2004
HERACERAM PRESS
K040859 · EIH
Heraeus Kulzer, Inc.
Dental · 48d
Cleared May 20, 2004
L-TENS
K041164 · GZJ
Fuji Dynamics Limited
Neurology · 17d
Cleared May 20, 2004
CLINICAL LABORATORY ANALYZING SYSTEM
K041230 · LFR
Hemocue, Inc.
Chemistry · 10d
Cleared May 20, 2004
ONE-STEP PREGNANCY TEST
K041273 · LCX
W.H.P.M., Inc.
Chemistry · 8d
Cleared May 19, 2004
FIRST SIGN DRUG OF ABUSE SCREENING TEST
K032575 · DKZ
W.H.P.M., Inc.
Chemistry · 273d
Cleared May 19, 2004
POWERED WHEELCHAIR
K033142 · ITI
Nats Corp.
Physical Medicine · 232d
Cleared May 19, 2004
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
K033688 · NRH
Micro Direct, Inc.
Chemistry · 177d
Cleared May 19, 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · DIS
Lin-Zhi International, Inc.
Toxicology · 156d
Cleared May 19, 2004
BONE CEMENT FOR CRANIOPLASTY
K040152 · GXP
Cardinalhealth
Neurology · 117d
Cleared May 19, 2004
A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
K040371 · DXN
A&D Engineering, Inc.
Cardiovascular · 92d
Cleared May 19, 2004
SINON
K040433 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 90d
Cleared May 19, 2004
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST...
K040445 · JXN
ACON Laboratories, Inc.
Toxicology · 89d
Cleared May 19, 2004
NOMAD FROM DYNAMIS MOBILITY LTD.
K040457 · ITI
Dynamis Mobility , Ltd.
Physical Medicine · 86d
Cleared May 19, 2004
PARADIGM LINK BLOOD GLUCOSE METER
K040603 · NBW
Becton, Dickinson & CO
Chemistry · 75d