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
74641–74664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2002
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
K020220 · LFL
Synergetics, Inc.
General & Plastic Surgery · 213d
Cleared Aug 23, 2002
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
K020400 · GWF
Meps, LLC
Neurology · 198d
Cleared Aug 23, 2002
3T VESSEL CANNULAS
K020768 · DWF
3t Medical Systems, LLC
Cardiovascular · 169d
Cleared Aug 23, 2002
CHITO-SEAL
K021062 · QSY
Abbott Vascular, Inc.
General & Plastic Surgery · 143d
Cleared Aug 23, 2002
BCLEAR
K021762 · FTC
Lumenis, Inc.
General & Plastic Surgery · 86d
Cleared Aug 23, 2002
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K021819 · NBW
Lifescan, Inc.
Chemistry · 80d
Cleared Aug 23, 2002
BRAINET
K021986 · GXY
Nicolet Biomedical, Inc.
Neurology · 66d
Cleared Aug 23, 2002
BOLTON PTA CATHETER
K021996 · LIT
Bolton Medical, Inc.
Cardiovascular · 66d
Cleared Aug 23, 2002
SURGISIS STAPLE LINE REINFORCEMENT
K022044 · OXE
Cook Biotech, Inc.
General & Plastic Surgery · 60d
Cleared Aug 23, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS...
K022072 · CIX
Precision Systems, Inc.
Chemistry · 58d
Cleared Aug 23, 2002
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
K022239 · JAK
Praxim
Radiology · 43d
Cleared Aug 23, 2002
LITE MINERAL OIL
K022332 · MQL
Intl., Inc.
Obstetrics & Gynecology · 36d
Cleared Aug 23, 2002
ALLGRAD AND ALLGRAD100
K022335 · MQL
Intl., Inc.
Obstetrics & Gynecology · 36d
Cleared Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 35d
Cleared Aug 23, 2002
UNI KNEE
K022437 · HRY
Encore Medical, L.P.
Orthopedic · 29d
Cleared Aug 23, 2002
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K022487 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Aug 23, 2002
MODEL OBC-63 BREAST ARRAY COIL
K022488 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Aug 23, 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · MSX
Datex-Ohmeda
Cardiovascular · 24d
Cleared Aug 23, 2002
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · JIR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Aug 23, 2002
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K022554 · JXG
Integra Neurosciences
Neurology · 21d
Cleared Aug 23, 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K022561 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 23, 2002
ENDIUS FLEXTIP BLADE
K022578 · HRX
Endius, Inc.
Orthopedic · 18d
Cleared Aug 23, 2002
MODIFICATION TO MEDAMICUS AXIA RSN
K022689 · DYB
Medamicus, Inc.
Cardiovascular · 10d
Cleared Aug 22, 2002
NANMA ADJUSTABLE CONSTRICTION RING
K013051 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 345d