FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80785–80808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 29, 2000
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF...
K002593 · KGO
Hartalega Sdn Bhd
General Hospital · 100d
Cleared Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K002721 · FTL
American Medical Systems, Inc.
General & Plastic Surgery · 90d
Cleared Nov 29, 2000
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD...
K002781 · DSA
Medical Cables, Inc.
Cardiovascular · 84d
Cleared Nov 29, 2000
MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
K002787 · DQA
Palco Labs, Inc.
Anesthesiology · 83d
Cleared Nov 29, 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
K002819 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION...
K002834 · HIR
Srs Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Nov 29, 2000
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
K002861 · JOJ
Steritec Products, Inc.
General Hospital · 77d