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
76873–76896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2002
KARMA DISCOVERY, MODEL KP40
K014127 · ITI
Vestil Manufacturing Corp.
Physical Medicine · 88d
Cleared Mar 15, 2002
COAPT SYSTMES ENDOTINE DEVICE
K014153 · HWC
Coapt Systems, Inc.
Orthopedic · 87d
Cleared Mar 15, 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Mar 15, 2002
NEW PROPHY POWDER
K014188 · KOJ
Dentsply Intl.
Dental · 84d
Cleared Mar 15, 2002
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
K020055 · JAA
Philips Medical Systems
Radiology · 66d
Cleared Mar 15, 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K020097 · JDW
Stryker Endoscopy
Orthopedic · 64d
Cleared Mar 15, 2002
MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND...
K020126 · MUK
Surx, Inc.
Gastroenterology & Urology · 59d
Cleared Mar 15, 2002
BELLEGLASS HP MODELING GEL
K020178 · EBG
Kerr Dental Materials Center
Dental · 56d
Cleared Mar 15, 2002
SIMIDUR S2
K020192 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
SIMIDUR KF PLUS
K020194 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
SIMIDUR S1S
K020195 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 52d
Cleared Mar 15, 2002
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
K020217 · JJX
Bayer Diagnostics Corp.
Chemistry · 52d
Cleared Mar 15, 2002
CLASSIC TENS
K020437 · GZJ
Care Rehab, Inc.
Neurology · 35d
Cleared Mar 15, 2002
GAZELLE WHEELCHAIR
K020536 · IOR
Alum Creek Wheelchair Co., Inc.
Physical Medicine · 24d
Cleared Mar 15, 2002
ENGUARD REMOTE PATIENT MONITOR
K020632 · QYX
Mennen Medical , Ltd.
Cardiovascular · 16d
Cleared Mar 15, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645 · DZE
BioHorizons Implant Systems, Inc.
Dental · 15d
Cleared Mar 14, 2002
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
K012350 · FWP
Porex Surgical, Inc.
General & Plastic Surgery · 232d
Cleared Mar 14, 2002
VECTORVISION TRAUMA
K012448 · HAW
Brainlab AG
Neurology · 225d
Cleared Mar 14, 2002
AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
K012796 · DXN
Amluck, Inc.
Cardiovascular · 205d
Cleared Mar 14, 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089 · CAH
Engineered Medical Systems
General Hospital · 178d
Cleared Mar 14, 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123 · BZG
Engineered Medical Systems
Anesthesiology · 176d
Cleared Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572 · HWC
Mitek Products
Orthopedic · 136d
Cleared Mar 14, 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · DYH
Pulpdent Corp.
Dental · 87d
Cleared Mar 14, 2002
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K014138 · DYH
Pulpdent Corp.
Dental · 87d