FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
112273–112296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1993
MULTITRAK-PLUS
K930894 · DSH
Zymed Medical Instrumentation
Cardiovascular · 252d
Cleared Nov 01, 1993
ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY
K930960 · LNH
Toshiba America Mri, Inc.
Radiology · 250d
Cleared Nov 01, 1993
AUDIOMETER DA 323
K933222 · EWO
Futuremed Div. of Future Impex Corp.
Ear, Nose, Throat · 123d
Cleared Nov 01, 1993
VISIONLINK INTERFILE CONVERSION SOFTWARE
K933372 · KPS
Evergreen Technologies, Inc.
Radiology · 115d
Cleared Nov 01, 1993
MODIFIED BRONCHOSCOPE AND ACCESSORIES
K933433 · EOQ
Fujinon, Inc.
Ear, Nose, Throat · 110d
Cleared Nov 01, 1993
PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS)
K933446 · KPS
Sudbury Systems, Inc.
Radiology · 111d
Cleared Nov 01, 1993
ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)
K933543 · EMA
Jedental Co., Inc.
Dental · 104d
Cleared Nov 01, 1993
JEDENTAL ZINC CEMENT IMPROVED
K933554 · EMA
Jedental Co., Inc.
Dental · 103d
Cleared Nov 01, 1993
AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH
K933597 · BYD
Arthro-Medic, Inc.
General Hospital · 98d
Cleared Nov 01, 1993
PORTABLE STANDARD
K934263 · IOR
Cloverleaf Cycle Co.
Physical Medicine · 62d
Cleared Nov 01, 1993
DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR
K934297 · IOR
Durable Medical Equipment, Inc.
Physical Medicine · 60d
Cleared Oct 29, 1993
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
K924452 · DYG
Baxter Healthcare Corp
Cardiovascular · 422d
Cleared Oct 29, 1993
BUFFALO FILTER REPLACEMENT FILTER #BSTM300
K930059 · FYD
Buffalo Filter Co., Inc.
General Hospital · 296d
Cleared Oct 29, 1993
BUFFALO FILTER REPLACEMENT FILTER #BILF-100
K930450 · FYD
Buffalo Filter Co., Inc.
General Hospital · 297d
Cleared Oct 29, 1993
GORE-TEX MICRO MESH
K931150 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 234d
Cleared Oct 29, 1993
FAN BEAM COLLIMATOR
K933256 · IYX
Siemens Gammasonics, Inc.
Radiology · 115d
Cleared Oct 29, 1993
HISTOFREEZER
K933327 · GEH
Solarcare, Inc.
General & Plastic Surgery · 113d
Cleared Oct 29, 1993
MICROLINE SCREEN FOR BARBITURATES
K933480 · DIS
Drug Screening Systems, Inc.
Toxicology · 106d
Cleared Oct 29, 1993
ELS 1000
K933548 · JJE
Bio-Tek Instruments, Inc.
Chemistry · 101d
Cleared Oct 28, 1993
DUODERM EXTRA THIN CGF DRESSING
K925990 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 337d
Cleared Oct 28, 1993
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 337d
Cleared Oct 28, 1993
DUODERM HYDROACTIVE DRESSING
K925993 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 337d
Cleared Oct 28, 1993
PHILIPS MRI BREAST COIL
K926275 · LNH
Philips Medical Systems, Inc.
Radiology · 318d
Cleared Oct 28, 1993
DMA AMYLASE PROCEDURE
K931559 · CIW
Data Medical Associates, Inc.
Chemistry · 212d