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
86977–87000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1999
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE
K984064 · KGO
Omni Intl., Inc.
General Hospital · 53d
Cleared Jan 08, 1999
PROMPT L-POP
K984246 · KLE
Espe Dental AG
Dental · 42d
Cleared Jan 08, 1999
PROCEM
K984248 · EMA
Espe Dental AG
Dental · 42d
Cleared Jan 08, 1999
STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
K984340 · EMA
Sterngold/Implamed
Dental · 35d
Cleared Jan 08, 1999
STERNVANTAGE VARNISH LC, MODEL 221001
K984341 · EBI
Sterngold/Implamed
Dental · 35d
Cleared Jan 08, 1999
NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
K984356 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 32d
Cleared Jan 08, 1999
MODEL ACTION AT II MANUAL WHEELCHAIR
K984447 · IOR
Invacare Corp.
Physical Medicine · 25d
Cleared Jan 08, 1999
MAXXIM
K984493 · IOR
Major Mobility Products, Inc.
Physical Medicine · 22d
Cleared Jan 07, 1999
CLEANCUT
K972335 · GEI
Medquest Products, Inc.
General & Plastic Surgery · 563d
Cleared Jan 07, 1999
PROTECH PLUS
K983547 · EBI
Protech, Inc.
Dental · 90d
Cleared Jan 07, 1999
XYZ SYSTEM
K983550 · HCC
Bio-Monitoring International Corp.
Neurology · 90d
Cleared Jan 07, 1999
BASIC, MEDIAN, DOMINANT, AND VARIO
K983552 · BTA
Medela, Inc.
General & Plastic Surgery · 90d
Cleared Jan 07, 1999
ACETAL DENTAL/PREFORMED CLASP
K983558 · EHP
Dentamax, Inc.
Dental · 86d
Cleared Jan 07, 1999
IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM
K983567 · GCJ
Med Images, Inc.
General & Plastic Surgery · 86d
Cleared Jan 07, 1999
PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
K983735 · EIA
Pall Medical
Dental · 77d
Cleared Jan 07, 1999
FIELD EFFECTS MRI SYSTEM
K983902 · LNH
Intermagnetics General Corp.
Radiology · 65d
Cleared Jan 07, 1999
LIGHT AGE EPICARE ALEXANDRITE LASER
K983977 · GEX
Light Age, Inc.
General & Plastic Surgery · 59d
Cleared Jan 07, 1999
FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
K984068 · ESW
Schneider (Europe) GmbH
Gastroenterology & Urology · 52d
Cleared Jan 07, 1999
FLUOROTEX SURGICAL MESH
K984197 · FTL
Bridger Biomed, Inc.
General & Plastic Surgery · 45d
Cleared Jan 07, 1999
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · KRH
Medtronic Vascular
Cardiovascular · 27d
Cleared Jan 07, 1999
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Jan 06, 1999
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
K982928 · CHL
Radiometer America, Inc.
Chemistry · 139d
Cleared Jan 06, 1999
PRECISION UV (VASURFILCON A)
K982988 · LPL
Wesley Jessen Corp.
Ophthalmic · 133d
Cleared Jan 06, 1999
OSSEOTITE DENTAL IMPLANTS
K983347 · DZE
Implant Innovations, Inc.
Dental · 105d