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
131665–131688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1989
STRETCHER TABLE
K884292 · KXH
Fischer Imaging Corp.
Radiology · 170d
Cleared Mar 31, 1989
MANDIBLE MANIPULATOR
K884308 · EKJ
Leonard Medical, Inc.
Dental · 169d
Cleared Mar 31, 1989
SUPER MAXX OTHERS (MULTIPLE) CONDOMS
K884468 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 157d
Cleared Mar 31, 1989
ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS
K884469 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 157d
Cleared Mar 31, 1989
KIMONO PLUS OTHERS (MULTIPLE) CONDOMS
K884470 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 157d
Cleared Mar 31, 1989
PHYSIOGARD SM 785
K885177 · DPS
Adam
Cardiovascular · 108d
Cleared Mar 31, 1989
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · KLS
Syva Co.
Chemistry · 98d
Cleared Mar 31, 1989
GX-2000 STATIONARY X-RAY GENERATOR
K890083 · IZO
Gendex Corp.
Radiology · 80d
Cleared Mar 31, 1989
CLEARFIL CR INLAY
K890123 · EBF
Kuraray Co.
Dental · 79d
Cleared Mar 31, 1989
SHEPARD INTRAUTERINE INSEMINATION CATHETER
K890301 · HDR
Cook Ob/Gyn
Obstetrics & Gynecology · 67d
Cleared Mar 31, 1989
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE
K890307 · HDB
Neward Enterprises, Inc.
Obstetrics & Gynecology · 67d
Cleared Mar 31, 1989
INTRAVASCULAR ADMINISTRATION SET
K890340 · FPA
Multi-Med, Inc.
General Hospital · 67d
Cleared Mar 31, 1989
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K890453 · DWZ
Dlp, Inc.
Cardiovascular · 60d
Cleared Mar 31, 1989
THE SPANTRON FRAME FREEZE
K890477 · LMA
Spantron, Inc.
Radiology · 59d
Cleared Mar 31, 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · DPS
Marquette Electronics, Inc.
Cardiovascular · 59d
Cleared Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
K890528 · CGA
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Mar 31, 1989
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019
K890798 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVE, LATEX
K890971 · LYY
Yaung Jenn Co., Ltd.
General Hospital · 32d
Cleared Mar 31, 1989
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
K891251 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891307 · LYY
Five Star Rubber Products
General Hospital · 18d
Cleared Mar 31, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K891322 · LYY
Duflex Products Sdn. Bhd.
General Hospital · 18d
Cleared Mar 31, 1989
PREFORMED TEMPLATE FOR TOOTH POSITIONER
K891328 · KMY
American Orthodontics
Dental · 21d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891368 · LYY
Zest Mark Industrial Co., Ltd.
General Hospital · 22d
Cleared Mar 31, 1989
ORTHODONTIC PLASTIC BRACKET
K891372 · DYW
American Orthodontics
Dental · 22d