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
76009–76032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2002
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)
K020330 · CAW
Pacific Consolidated Industries Llp
Anesthesiology · 71d
Cleared Apr 12, 2002
APC PLUS ADHESIVE
K020394 · DYH
3M Unitek
Dental · 65d
Cleared Apr 12, 2002
MITYVAC MERLIN, MODEL 10027
K020447 · HDB
Prism Enterprises, Inc.
Obstetrics & Gynecology · 60d
Cleared Apr 12, 2002
STATIC CRANIOPLASTY ORTHOSIS
K020448 · MVA
Eastern Cranial Affiliates
Neurology · 60d
Cleared Apr 12, 2002
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE...
K020496 · GKZ
Sysmex Corporation of America
Hematology · 57d
Cleared Apr 12, 2002
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
K020575 · MRR
Elan Diagnostics
Chemistry · 50d
Cleared Apr 12, 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/...
K020662 · MMI
Ortho-Clinical Diagnostics
Chemistry · 42d
Cleared Apr 12, 2002
DEPILASE TWIN YAG LASER SYSTEM
K020697 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 39d
Cleared Apr 12, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
K020817 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 30d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS...
K020824 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Apr 12, 2002
EFILM WORKSTATION WITH MODULES
K020995 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Apr 12, 2002
ABP-2000 G-3
K021029 · DXN
Biotrac, Inc.
Cardiovascular · 14d
Cleared Apr 11, 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 601d
Cleared Apr 11, 2002
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
K011068 · KTL
Rhigene, Inc.
Immunology · 367d
Cleared Apr 11, 2002
ZOLL PAD WITH CPR AID
K011541 · MKJ
Zoll Medical Corp
Cardiovascular · 328d
Cleared Apr 11, 2002
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
K012956 · JOW
Hygia Health Services, Inc.
Cardiovascular · 219d
Cleared Apr 11, 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
K013160 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 202d
Cleared Apr 11, 2002
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
K020099 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Apr 11, 2002
INTRAORAL CAMERA ME-15
K020206 · EIA
Dent Corp. Research & Development
Dental · 79d
Cleared Apr 11, 2002
AVON PATELLAR COMPONENT
K020841 · KRR
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 11, 2002
MODIFICATION TO FOX PTA CATHETER
K020854 · LIT
Jomed AG
Cardiovascular · 27d
Cleared Apr 10, 2002
IMMEDIATE STABILIZING DEVICE (ISD)
K011524 · DZE
"O" Co., Inc.
Dental · 328d
Cleared Apr 10, 2002
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
K020089 · NIE
The Kendall Company
Gastroenterology & Urology · 90d