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

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175,820 results
132313–132336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1989
BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)
K891366 · FRC
Mdt Corp., Inc.
General Hospital · 26d
Cleared Mar 29, 1989
COMPLE-SAFE VINYL EXAMINATION GLOVES
K891369 · LYZ
Universal Gloves Corp.
General Hospital · 20d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891378 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 20d
Cleared Mar 29, 1989
GREENE-ARMYTAGE HEMOSTATIC FORCEPS
K891397 · KNA
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 15d
Cleared Mar 29, 1989
CORSON MYOMA GRASPING FORCEPS
K891399 · KNA
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 15d
Cleared Mar 29, 1989
UTERINE CLAMPS
K891402 · HGC
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 15d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891425 · LYY
Encore Technology, Inc.
General Hospital · 15d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891511 · LYY
Oon Corp. Resources
General Hospital · 13d
Cleared Mar 28, 1989
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
K884184 · LCP
Sigma Diagnostics, Inc.
Chemistry · 175d
Cleared Mar 28, 1989
TECHNICON DAX(TM) SYSTEM
K885203 · JJG
Technicon Instruments Corp.
Chemistry · 99d
Cleared Mar 28, 1989
QMS(TM) - THEOPHYLLINE
K885263 · JQX
Seradyn, Inc.
Chemistry · 95d
Cleared Mar 28, 1989
VS-1 MODEL NUMBER 251K PULSE GENERATOR
K885267 · DXY
Pacesetter Systems
Cardiovascular · 96d
Cleared Mar 28, 1989
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · DIH
Sigma Chemical Co.
Chemistry · 96d
Cleared Mar 28, 1989
STAR 36
K890066 · IZO
Transworld X-Ray Corp.
Radiology · 78d
Cleared Mar 28, 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 28, 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Mar 28, 1989
VENTREX COATED TUBE HCG
K890549 · JHI
Ventrex Laboratories, Inc.
Chemistry · 53d
Cleared Mar 28, 1989
COTUBE(TM) TSH IRMA
K890802 · JLW
Bio-Rad
Chemistry · 40d
Cleared Mar 28, 1989
CENTURION CIRCLAMP
K890897 · HFX
Tri-State Hospital Supply Corp.
Obstetrics & Gynecology · 34d
Cleared Mar 28, 1989
KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0
K890927 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 500 ANALYZER
K890928 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 750 SERIES ANALYZER
K890929 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
K890997 · KEA
Atlantic Wholesale, Inc.
Chemistry · 29d
Cleared Mar 28, 1989
MAGNESIUM REAGENT
K891355 · JGJ
Medical Analysis Systems, Inc.
Chemistry · 18d