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
144721–144744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1986
SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
K860600 · HRS
3M Company
Orthopedic · 22d
Cleared Mar 13, 1986
MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPS
K860683
Medcomp Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Mar 13, 1986
KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA
K860691 · LMC
Eastman Kodak Company
Radiology · 16d
Cleared Mar 13, 1986
MEDICAL X-RAY FILM
K860797 · IWZ
India-America Trading Co.
Radiology · 9d
Cleared Mar 13, 1986
CONTINUCATH
K860808 · CCE
Orange Medical Instruments, Inc.
Anesthesiology · 9d
Cleared Mar 13, 1986
RESPIRONICS SECUREASY
K860845 · CBH
Respironics, Inc.
Anesthesiology · 7d
Cleared Mar 12, 1986
ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY
K852168 · FRN
Y
General Hospital · 296d
Cleared Mar 12, 1986
RUBALEX
K852788 · LQN
Orion Corp.
Microbiology · 254d
Cleared Mar 12, 1986
SONOLAYER S, SSH-60A/SDS-60A
K853115 · DXK
Toshiba Medical Systems
Cardiovascular · 231d
Cleared Mar 12, 1986
LARYNGEAL
K853726 · FWN
Hood Laboratories
Ear, Nose, Throat · 187d
Cleared Mar 12, 1986
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
K853856 · HFM
Aequitron Medical, Inc.
Obstetrics & Gynecology · 177d
Cleared Mar 12, 1986
FLEXIBLE GRASPING FORCEPS
K854112 · EWL
Hood Laboratories
Ear, Nose, Throat · 155d
Cleared Mar 12, 1986
HEMATOLOGY CALIBRATOR CONTROL
K854166 · KRZ
Interscience Diagnostics, Inc.
Hematology · 148d
Cleared Mar 12, 1986
DUMON/HARRELL
K854414 · EOQ
Bryan Corp.
Ear, Nose, Throat · 128d
Cleared Mar 12, 1986
S.T.P.B SOFT TISSUES PROTECTIVES BLADES
K854467 · EEJ
Nortex USA, Inc.
Dental · 126d
Cleared Mar 12, 1986
GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT
K854555 · IYO
Gl Ultrasound , Ltd.
Radiology · 118d
Cleared Mar 12, 1986
GOLD AIR, GOLD LIGHT
K854645 · EFB
Alpine Dental Equipment Co.
Dental · 113d
Cleared Mar 12, 1986
EZ-ON TUBING CONDITIONER (LUBRICANT)
K854700
Almore Intl., Inc.
Dental · 111d
Cleared Mar 12, 1986
COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
K854938 · JPA
Diatech, Inc.
Hematology · 92d
Cleared Mar 12, 1986
PERINATAL COMPUTER SYS MODEL 100A & 100B
K855044 · HGM
Peritronics Research and Development,...
Obstetrics & Gynecology · 85d
Cleared Mar 12, 1986
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
K855064 · CAK
Cobe Laboratories, Inc.
General Hospital · 84d
Cleared Mar 12, 1986
CONVEX PROBE, PVE-382M
K855124 · IYO
Toshiba Medical Systems
Radiology · 79d
Cleared Mar 12, 1986
BEHIND THE EAR HEARING AIDS MODEL
K855240 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 71d
Cleared Mar 12, 1986
AM 12, HEARING AID
K860007 · ESD
Electone, Inc.
Ear, Nose, Throat · 68d