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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
131713–131736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1989
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
K891011 · ESD
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
K891247 · ESF
Siemens Hearing Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
K891248 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 303 ASP
K891249 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 264 D-PP-PC
K891250 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891291 · LYY
Cp Products, Inc.
General Hospital · 19d
Cleared Mar 29, 1989
AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX)
K891298 · LYY
Medi Tex, Inc.
General Hospital · 16d
Cleared Mar 29, 1989
REID ENDOCERVICAL SPREADER
K891347 · HDC
Simpson/Basye, Inc.
Obstetrics & Gynecology · 19d
Cleared Mar 29, 1989
CAMPION CERVICAL HOOK
K891349 · HDC
Simpson/Basye, Inc.
Obstetrics & Gynecology · 19d
Cleared Mar 29, 1989
NEWPORT CERVICAL MANIPULATOR
K891350 · HDC
Simpson/Basye, Inc.
Obstetrics & Gynecology · 19d
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