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
74569–74592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2002
3D KNEE
K020114 · JWH
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704 · LCD
Roche Diagnostics Corp.
Toxicology · 130d
Cleared Jul 12, 2002
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
K020735 · GXY
Cathay International, Ltd.
Neurology · 128d
Cleared Jul 12, 2002
EXTENSION SET, MODELS 1911-512
K020926 · FPA
Epimed International, Inc.
General Hospital · 113d
Cleared Jul 12, 2002
MECHANICAL DAILY USE WHEELCHAIR
K021075 · IOR
First World Services, Inc.
Physical Medicine · 101d
Cleared Jul 12, 2002
NERVUS MONITOR
K021185 · OLV
Taugagreining HF
Neurology · 88d
Cleared Jul 12, 2002
AUTOALIGN
K021191 · LLZ
Cortechs Labs, Inc.
Radiology · 88d
Cleared Jul 12, 2002
PRIMECHAIR
K021199 · ITI
Dalton Medical Corp.
Physical Medicine · 87d
Cleared Jul 12, 2002
ENDOCERVICAL BLOCK NEEDLE
K021224 · HEE
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 12, 2002
ATAC PAK BUN REAGENT
K021385 · CDQ
Elan Diagnostics
Chemistry · 71d
Cleared Jul 12, 2002
TOPCUT
K021525 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 63d
Cleared Jul 12, 2002
HEMOSORB
K021581 · QSY
On Site Gas Systems, Inc.
General & Plastic Surgery · 59d
Cleared Jul 12, 2002
QAB2A IGM ELISA KIT HRP
K021610 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
QAB2A IGG ELISA KIT HRP
K021611 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624 · JJX
Bionostics, Inc.
Chemistry · 57d
Cleared Jul 12, 2002
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · HIB
Cypress Medical Products, Ltd.
Obstetrics & Gynecology · 52d
Cleared Jul 12, 2002
HEMADERM COTAINING HEMADEX CLOTTING BEADS
K021678 · QSY
Medafor, Inc.
General & Plastic Surgery · 52d
Cleared Jul 12, 2002
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697 · JJX
Bionostics, Inc.
Chemistry · 51d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874 · DXG
Abbott Laboratories
Cardiovascular · 35d
Cleared Jul 12, 2002
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
K021927 · LXG
Biomet, Inc.
Hematology · 30d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND...
K021970 · LPH
Implex Corp.
Orthopedic · 25d
Cleared Jul 12, 2002
HORIZONS CYTOLOGY BRUSH
K021998 · FDX
Horizons Intl. Corp.
Gastroenterology & Urology · 23d
Cleared Jul 12, 2002
MPOWER, MODEL 712 SERIES
K022001 · KPS
Positron Corp.
Radiology · 23d
Cleared Jul 12, 2002
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K022053 · JHO
Sebia
Chemistry · 18d