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
77785–77808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2001
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
K012240 · FYA
Mercan AB
General Hospital · 90d
Cleared Oct 15, 2001
CHIBA NEEDLE
K012358 · FCG
Ispg, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 15, 2001
EAR MUFFINS
K012384 · HCC
Bio-Logic Systems Corp.
Neurology · 80d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · DJR
ACON Laboratories, Inc.
Toxicology · 66d
Cleared Oct 15, 2001
FAS ENDOLUMINAL BRUSH
K012641 · LJS
Fas Medical , Ltd.
General Hospital · 63d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
POWDERED LATEX EXAMINATION GLOVES
K013026 · LYY
Great Glove (Thailand) Co. , Ltd.
General Hospital · 35d
Cleared Oct 15, 2001
MODIFICATION TO ALPHA DX SYSTEM
K013118 · JHX
First Medical, Inc.
Chemistry · 27d
Cleared Oct 15, 2001
MT ALERT INFUSION MONITOR
K013121 · FLN
Sierra Biosearch, Inc.
General Hospital · 27d
Cleared Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600...
K013134 · DHB
Diagnostic Products Corp.
Immunology · 26d
Cleared Oct 15, 2001
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · FPA
Terumo Medical Corp.
General Hospital · 24d
Cleared Oct 12, 2001
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR...
K004005 · QPB
Mentor Corp.
General & Plastic Surgery · 290d
Cleared Oct 12, 2001
MAGELLAN-2200, MODEL 1
K010613 · BSZ
Oceanic Medical Products, Inc.
Anesthesiology · 225d
Cleared Oct 12, 2001
CYCLOTEC AMT CTI TENS DEVICE
K010615 · GZJ
Cyclotec
Neurology · 225d
Cleared Oct 12, 2001
INSTRUMENT DAMPING PORT
K011373 · DRC
Medcanica, Inc.
Cardiovascular · 161d
Cleared Oct 12, 2001
SDI SB OFFICE, MODEL 29-
K011470 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 151d
Cleared Oct 12, 2001
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE...
K012206 · DQK
Cambridge Heart, Inc.
Cardiovascular · 91d
Cleared Oct 12, 2001
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
K012218 · DRO
The Ludlow Company LP
Cardiovascular · 88d
Cleared Oct 12, 2001
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN...
K012402 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 77d
Cleared Oct 12, 2001
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K012404 · DRO
Katecho, Inc.
Cardiovascular · 74d
Cleared Oct 12, 2001
BIOMEDICS UV MULTIFOCAL
K012425 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 74d
Cleared Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM,...
K012883 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Oct 12, 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
K013057 · MAI
Bionx Implants, Inc.
Orthopedic · 30d