Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
71041–71064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2003
GLOBAL PRESS-FIT STEM
K032385 · LPH
Global Medical Co.
Orthopedic · 87d
Cleared Oct 30, 2003
A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS
K032499 · DXN
A&D Engineering, Inc.
Cardiovascular · 78d
Cleared Oct 30, 2003
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · DQK
Ge Medical Systems Information...
Cardiovascular · 77d
Cleared Oct 30, 2003
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
K032656 · IYN
Ge Med. Systems Ultrasound & Prim....
Radiology · 63d
Cleared Oct 30, 2003
ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP...
K032676 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 62d
Cleared Oct 30, 2003
MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
K032731 · IOR
Turbo Wheelchair Co., Inc.
Physical Medicine · 57d
Cleared Oct 30, 2003
GLYCOHEMOSURE HBA1C CONTROL
K032791 · GGM
Quantimetrix Corp.
Chemistry · 52d
Cleared Oct 30, 2003
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A)...
K032798 · JHM
Dade Behring, Inc.
Chemistry · 51d
Cleared Oct 30, 2003
ADVANTAGE 4D OPTION
K032915 · JAK
Ge Medical Systems, LLC
Radiology · 38d
Cleared Oct 30, 2003
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891,...
K033016 · GZB
Medtronic Neurological
Neurology · 34d
Cleared Oct 30, 2003
HANDIVIPP
K033125 · IOR
Handinor USA, Inc.
Physical Medicine · 30d
Cleared Oct 30, 2003
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
K033131 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 30, 2003
MECHANICAL WHEEHCHAIR
K033141 · IOR
Pacific Medical Suppliers, Inc.
Physical Medicine · 30d
Cleared Oct 30, 2003
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
K033172 · GEX
Candela Corp.
General & Plastic Surgery · 30d
Cleared Oct 30, 2003
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · JEY
Inion , Ltd.
Dental · 28d
Cleared Oct 30, 2003
ENSITE SYSTEM
K033211 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 27d
Cleared Oct 30, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS
K033212 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 27d
Cleared Oct 30, 2003
ARTHROCARE ENT PLASMA WANDS
K033257 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Oct 29, 2003
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
K023000 · IPF
Home Care Technology Co., Ltd.
Physical Medicine · 415d
Cleared Oct 29, 2003
AMSURE FOLEY CATHETER
K030120 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 289d
Cleared Oct 29, 2003
STICK FLOW
K031341 · EBF
Stick Tech , Ltd.
Dental · 184d
Cleared Oct 29, 2003
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH...
K032024 · LZA
Shen Wei (Usa), Inc.
General Hospital · 121d
Cleared Oct 29, 2003
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 114d
Cleared Oct 29, 2003
PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
K032119 · KCT
Paragon Medical, Inc.
General Hospital · 112d