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
117361–117384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1992
BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED)
K914999 · IPF
Bt Medical Co., Inc.
Physical Medicine · 168d
Cleared Apr 23, 1992
BACT/ALERT PEDI-BACT
K920249 · MDB
Organon Teknika Corp.
Microbiology · 93d
Cleared Apr 23, 1992
OPTIEAR
K920322 · ERA
Nankivell Industries, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 23, 1992
DRESSING CHANGE TRAY
K920339 · FRG
Medikmark, Inc.
General Hospital · 90d
Cleared Apr 23, 1992
SUTURE REMOVAL KIT
K920340 · KKX
Medikmark, Inc.
General Hospital · 90d
Cleared Apr 23, 1992
LACERATION TRAYS
K920341 · KKX
Medikmark, Inc.
General Hospital · 90d
Cleared Apr 23, 1992
AUGUSTINE STYLET
K920468 · BSR
Augustine Medical, Inc.
Anesthesiology · 87d
Cleared Apr 23, 1992
AUGUSTINE GUIDE KIT
K921166 · CCW
Augustine Medical, Inc.
Anesthesiology · 43d
Cleared Apr 23, 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · CBK
Respironics, Inc.
Anesthesiology · 15d
Cleared Apr 22, 1992
BACTERIA FILTER
K912577 · CAH
Vital Signs, Inc.
General Hospital · 315d
Cleared Apr 22, 1992
MYDAS(TM)-MB2/MYDAS(TM)-MB
K913380 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 268d
Cleared Apr 22, 1992
ALBICANS SURE
K913426 · JXC
Jrga Diagnostics
Microbiology · 265d
Cleared Apr 22, 1992
RUBELLA IGM ELISA TEST SYSTEM
K914028 · LFX
Zeus Scientific, Inc.
Microbiology · 225d
Cleared Apr 22, 1992
PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45
K914445 · KGO
Smith & Nephew Perry
General Hospital · 201d
Cleared Apr 22, 1992
FEMOSTOP
K915280 · DXC
Radi Medical Systems AB
Cardiovascular · 149d
Cleared Apr 22, 1992
REGULATOR FLOWMETER
K915505 · CAN
Lifeguard Medical Products, Inc.
Anesthesiology · 135d
Cleared Apr 22, 1992
ORTHO HSV ANTIGEN ELISA TEST
K915551 · LGC
Ortho Diagnostic Systems, Inc.
Microbiology · 133d
Cleared Apr 22, 1992
SLT SPECTRA
K915689 · JJQ
Slt Labinstruments, Inc.
Chemistry · 121d
Cleared Apr 22, 1992
SLT 340 ATTC
K915690 · JJQ
Slt Labinstruments, Inc.
Chemistry · 121d
Cleared Apr 22, 1992
BACTEC 9240 SYSTEM
K915796 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 120d
Cleared Apr 22, 1992
EASY TOUCH LATEX EAM GLOVES
K920174 · LYY
Simpex, Inc.
General Hospital · 99d
Cleared Apr 22, 1992
NIACIN CONTROL DISKS
K920257 · JTO
Remel Co.
Microbiology · 92d
Cleared Apr 22, 1992
EZ GAUZE SPONGE
K920269 · NAB
Cal West Trading Co.
General & Plastic Surgery · 92d
Cleared Apr 22, 1992
RIGHT ATRIAL CATHETER KITS
K920331 · DQY
Akcess Medical Products, Inc.
Cardiovascular · 90d