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
118417–118440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1992
CDI(TM) 300, 400 & 100, MODIFICATION
K915255 · DRY
3M Company
Cardiovascular · 58d
Cleared Jan 15, 1992
CDI(TM) H/S CUVETTE, MODIFICATION
K915265 · DRY
3M Company
Cardiovascular · 57d
Cleared Jan 15, 1992
CUSTOM CANAL HEARING AID
K915346 · ESD
Dicta Laboratories
Ear, Nose, Throat · 50d
Cleared Jan 15, 1992
DIGITOXIN FPIA CALIBRATOR SET
K915464 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 44d
Cleared Jan 15, 1992
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
K915732 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jan 14, 1992
MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
K910742 · KXO
Graphic Controls Corp.
Obstetrics & Gynecology · 327d
Cleared Jan 14, 1992
MANI DIA-BURS
K913651 · DZP
The Lahr Consulting Group, Inc.
Dental · 151d
Cleared Jan 14, 1992
ORTHO LIGHT CURE
K913854 · DYH
Ortho Source
Dental · 140d
Cleared Jan 14, 1992
SONO(R) -CEM
K913966 · EBF
Espe GmbH (Us)
Dental · 131d
Cleared Jan 14, 1992
L.C.S. 2000 SYSTEM
K914591 · GEH
Stiefel Research Institute, Inc.
General & Plastic Surgery · 90d
Cleared Jan 14, 1992
PHOTAC-BOND APLICAP, MODIFICATION
K915005 · EMA
Espe GmbH (Us)
Dental · 68d
Cleared Jan 14, 1992
ELECTRODE USING PROMEON RG-60 SERIES GEL
K915333 · GXY
Labeltape Meditect, Inc.
Neurology · 49d
Cleared Jan 14, 1992
AMOENA AFFINITY MODEL #802
K915382 · KCZ
Coloplast Corp.
General & Plastic Surgery · 46d
Cleared Jan 14, 1992
KOPAN'S TARGET
K915417 · GAA
Medical Device Technologies, Inc.
General & Plastic Surgery · 43d
Cleared Jan 14, 1992
INTERSEGMENTAL TRACTION TABLE
K915784 · JFB
Tjn Manufacturing,Inc.
Physical Medicine · 21d
Cleared Jan 13, 1992
OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES
K904940 · FJL
Olympus Corp.
Gastroenterology & Urology · 438d
Cleared Jan 13, 1992
SELECTRA AND TUBING SETS
K910173 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 363d
Cleared Jan 13, 1992
OREGON FIXATION SCREW
K910976 · HWC
Acu Med, Inc.
Orthopedic · 312d
Cleared Jan 13, 1992
INTERLOCKING FEMORAL NAILING SYSTEM
K912930 · HSB
Stryker Corp.
Orthopedic · 192d
Cleared Jan 13, 1992
MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC
K913368 · BTT
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 173d
Cleared Jan 13, 1992
PHOENIX BURR HOLE BUTTON, BURR 1
K913490 · GXR
Phoenix Bioengineering, Inc.
Neurology · 160d
Cleared Jan 13, 1992
TRACHEOSTOMY MASK
K913501 · BYG
B & F Medical Products, Inc.
Anesthesiology · 159d
Cleared Jan 13, 1992
COWBOY
K913611 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 152d
Cleared Jan 13, 1992
TI-FIT FEMORAL COMPONENT
K914343 · LWJ
Smith & Nephew Richards, Inc.
Orthopedic · 108d