FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89089–89112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1998
CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL...
K981795 · JIX
Thermo Bioanalysis Corp.
Chemistry · 22d
Cleared Jun 12, 1998
B-D PEN ULTRA
K981797 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 22d
Cleared Jun 12, 1998
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
K981864 · JJX
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Jun 11, 1998
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
K964153 · DXN
Rossmax International , Ltd.
Cardiovascular · 603d
Cleared Jun 11, 1998
KILOWIN
K971214 · GWE
Cadwell Laboratories, Inc.
Neurology · 435d
Cleared Jun 11, 1998
DRYALYSATE CONCENTRATE
K980659 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 111d
Cleared Jun 11, 1998
JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID
K980899 · MQX
Kenshin Trading Corp.
General Hospital · 93d
Cleared Jun 11, 1998
BODYSTAT DUALSCAN 2005
K980971 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 87d
Cleared Jun 11, 1998
BECTON DICKINSON SYRINGE
K980987 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Jun 11, 1998
3M M.G. MATERIAL
K981325 · ELW
3M Company
Dental · 59d
Cleared Jun 11, 1998
ODONTOSURGE 2
K981390 · EKZ
Periogiene
Dental · 56d
Cleared Jun 11, 1998
HDL
K981580 · LBS
Abbott Laboratories
Chemistry · 38d
Cleared Jun 11, 1998
QTEXX POWDERFREE LATEX EXAMINATION GLOVES
K981767 · LYY
Latexx Partners Bhd.
General Hospital · 23d
Cleared Jun 10, 1998
THE AMPLANTZ GOOSE NECK MICROSNARE
K970668 · DQY
Microvena Corp.
Cardiovascular · 471d
Cleared Jun 10, 1998
AD-TECH'S SPINAL ELECTRODE
K973454 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 272d
Cleared Jun 10, 1998
ARTHREX PUDDU OSTEOTOMY SYSTEM
K973812 · HRS
Arthrex, Inc.
Orthopedic · 246d
Cleared Jun 10, 1998
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
K980047 · KQO
Yeongdong Pharmaceutical Corp.
Chemistry · 155d
Cleared Jun 10, 1998
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121 · KWP
Aesculap, Inc.
Orthopedic · 147d
Cleared Jun 10, 1998
STERILE, POWDERFREE LATEX EXAMINATION GLOVE
K980785 · LYY
London Intl., LLC
General Hospital · 100d
Cleared Jun 10, 1998
KAPLAN-SIMPSON INFUSASLEEVE II
K980957 · QEY
Localmed, Inc.
Cardiovascular · 86d
Cleared Jun 10, 1998
IN-CHECK INSPIRATORY FLOWMETER
K980960 · BZH
Clement Clarke Intl., Ltd.
Anesthesiology · 86d
Cleared Jun 10, 1998
ROGACHEFSKY DISTAL RADIUS PLATES
K981283 · HRS
Howmedica, Inc.
Orthopedic · 63d
Cleared Jun 10, 1998
ACE T UPTAKE REAGENT TU CALIBRATORS
K981375 · KHQ
Schiapparelli Biosystems, Inc.
Chemistry · 55d
Cleared Jun 10, 1998
ACE T4 REAGENT T4 CALIBRATORS
K981377 · KLI
Schiapparelli Biosystems, Inc.
Chemistry · 55d