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
79681–79704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2001
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
K010129 · LNI
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Apr 05, 2001
VERSALUX
K010133 · EBZ
Centrix, Inc.
Dental · 78d
Cleared Apr 05, 2001
TOTAL CURE
K010196 · EBF
Bisco, Inc.
Dental · 73d
Cleared Apr 05, 2001
PJUR EROS WATER FORMULATION
K010199 · NUC
L.C.C. Pjur Group Germany
Obstetrics & Gynecology · 73d
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · DCK
Beckman Coulter, Inc.
Immunology · 70d
Cleared Apr 05, 2001
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
K010377 · KZH
Minimed, Inc.
General Hospital · 56d
Cleared Apr 05, 2001
VERDICT -II BAR/BZO
K010561 · DIS
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Apr 05, 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564 · DKZ
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Apr 05, 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · JHI
Sa Scientific, Inc.
Chemistry · 36d
Cleared Apr 05, 2001
RECONSTITUTION KIT & VIAL CONNECTOR
K010623 · LHI
Bioject, Inc.
General Hospital · 34d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9068 T
K010653 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9078 T
K010654 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
COPELAND RESURFACING HUMERAL HEADS
K010664 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 30d
Cleared Apr 05, 2001
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K010829 · LYZ
General Gloves Corp.
General Hospital · 16d
Cleared Apr 05, 2001
THE LIBERATOR WHEELCHAIR
K010859 · ITI
Liberator Wheelchairs, Inc.
Physical Medicine · 14d
Cleared Apr 05, 2001
STS-T LITHOTRIPTER, MODEL STS-T
K010900 · LNS
Medstone Intl., Inc.
Gastroenterology & Urology · 10d
Cleared Apr 05, 2001
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · DRB
Medtronic Vascular
Cardiovascular · 10d
Cleared Apr 05, 2001
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K010912 · MSX
Data Critical Corp.
Cardiovascular · 9d
Cleared Apr 04, 2001
FLO-BOOT
K003272 · BXB
Discovery Group, LLC
Physical Medicine · 168d
Cleared Apr 04, 2001
MINI FIBER ENDOSCOPES
K003417 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 153d
Cleared Apr 04, 2001
IVS TUNNELLER
K010035 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Apr 04, 2001
GUIDANT AXIUS CORONARY SHUNT
K010117 · DXC
Cardiothoracic Systems, Inc.
Cardiovascular · 78d
Cleared Apr 04, 2001
SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL...
K010737 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 23d