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
69913–69936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2003
STERISIL ANTIMICROBIAL TUBING AND BOTTLE
K031681 · EIA
Sterisil
Dental · 153d
Cleared Oct 30, 2003
TOPKIN WOUND DRESSING
K031684 · QSZ
Biomet Merck GmbH
General & Plastic Surgery · 153d
Cleared Oct 30, 2003
DIO-DENT 10 DENTAL DIODE LASER
K031819 · GEX
Msq (M2) , Ltd.
General & Plastic Surgery · 140d
Cleared Oct 30, 2003
PROFUSION BONE VOID FILLER KIT
K031838 · MQV
Biogeneration
Orthopedic · 136d
Cleared Oct 30, 2003
FERTELL FEMALE FERTILITY TEST
K032002 · NGA
Genosis, Inc.
Chemistry · 125d
Cleared Oct 30, 2003
ENDOHELIX ENDARTERECTOMY DEVICE
K032105 · DWX
Endarx, Inc.
Cardiovascular · 114d
Cleared Oct 30, 2003
BONESOURCE HAC FAST SETTING CEMENT
K032366 · GXP
Stryker Instruments
Neurology · 90d
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