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
81385–81408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2000
MEDCOMP BIO-CATH CATHETER LINE
K003110 · LJS
Medcomp
General Hospital · 58d
Cleared Dec 01, 2000
SIREMOBIL ISO-C 3D
K003266 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Dec 01, 2000
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · LIT
NuMED, Inc.
Cardiovascular · 43d
Cleared Dec 01, 2000
WIRECLIP TORQUER
K003398 · DQX
Boston Scientific Corporation...
Cardiovascular · 30d
Cleared Dec 01, 2000
DEPUY C-STEM SYSTEM
K003421 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · FIB
Fresenius Medical Care North America
Gastroenterology & Urology · 25d
Cleared Dec 01, 2000
PENTRA 5D
K003534 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806 · HIG
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 262d
Cleared Nov 30, 2000
OS-2000 OPTICAL SONOGRAPHY SYSTEM
K001510 · NCS
Advanced Diagnostics, Inc.
Radiology · 199d
Cleared Nov 30, 2000
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION)...
K002493 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 108d
Cleared Nov 30, 2000
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
K002740 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 30, 2000
NICOLET VASOGUARD
K002766 · JOP
Nicolet Biomedical
Cardiovascular · 86d
Cleared Nov 30, 2000
COLTENE AURA COMPOMER RESTORATIVE SYSTEM
K003034 · EBF
Coltene/Whaledent, Inc.
Dental · 63d
Cleared Nov 30, 2000
FASTPACK CALIBRATORS
K003096 · JIT
Qualigen, Inc.
Immunology · 58d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
K003239 · JJS
Bio-Rad
Chemistry · 44d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
K003242 · JJS
Bio-Rad
Chemistry · 44d
Cleared Nov 30, 2000
V-40/C-TAPER ADAPTER SLEEVE
K003379 · LZO
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Nov 30, 2000
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K003429 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Nov 30, 2000
DISPOSABLE PRESSURE MONITOR
K003497 · CAP
Engineered Medical Systems
Anesthesiology · 17d
Cleared Nov 29, 2000
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
K000004 · DYB
Daig Corp.
Cardiovascular · 331d
Cleared Nov 29, 2000
SENSAIRE DIAGNOSTIC SPIROMETER
K001278 · BZG
Qrs Diagnostic, LLC
Anesthesiology · 222d
Cleared Nov 29, 2000
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · LIP
Trinity Biotech, Plc
Microbiology · 197d
Cleared Nov 29, 2000
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K002010 · DJR
OraSure Technologies, Inc.
Toxicology · 149d
Cleared Nov 29, 2000
DELTA 32 AND DELTA 32 TACT
K002472 · IZH
Instrumentarium Imaging, Inc.
Radiology · 110d