FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87481–87504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1999
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL...
K982272 · DQX
Biotronik, Inc.
Cardiovascular · 193d
Cleared Jan 08, 1999
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC...
K982754 · FWF
A.Stein - Regulatory Affairs Consulting
General & Plastic Surgery · 155d
Cleared Jan 08, 1999
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K983569 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 87d
Cleared Jan 08, 1999
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K983574 · EGS
Dentalez Group
Dental · 87d
Cleared Jan 08, 1999
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
K983607 · MML
Labtician Ophthalmics, Inc.
Ophthalmic · 86d
Cleared Jan 08, 1999
MANAN SPINAL NEEDLES
K983620 · BSP
Manan Medical Products, Inc.
Anesthesiology · 85d
Cleared Jan 08, 1999
JMS DIALYZER PRIMING SET
K983707 · KOC
Jms Co., Ltd.
Gastroenterology & Urology · 79d
Cleared Jan 08, 1999
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
K983962 · KGO
Cardinal Health-Medical Products and...
General Hospital · 63d
Cleared Jan 08, 1999
UNIFINE
K983994 · FMF
Owen Mumford USA, Inc.
General Hospital · 60d
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