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
89593–89616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
K980289 · KGI
Norland Corp.
Radiology · 137d
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
K980569 · KGI
Norland Corp.
Radiology · 119d
Cleared Jun 12, 1998
RIGID CULDOSCOPE AND ACCESSORIES
K980972 · HEW
Circon Corp.
Obstetrics & Gynecology · 88d
Cleared Jun 12, 1998
FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE
K980979 · CCK
Fukuda Denshi USA, Inc.
Anesthesiology · 87d
Cleared Jun 12, 1998
VARIAN XIMATRON SCAN VISION CT
K981056 · KPR
Varian Medical Systems, Inc.
Radiology · 81d
Cleared Jun 12, 1998
PHOS
K981118 · CEO
Abbott Laboratories
Chemistry · 77d
Cleared Jun 12, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K981638 · DCK
Beckman Coulter, Inc.
Immunology · 35d
Cleared Jun 12, 1998
ALBG
K981758 · CIX
Abbott Laboratories
Chemistry · 24d
Cleared Jun 12, 1998
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · DJG
Princeton BioMeditech Corp.
Toxicology · 24d
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