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
73417–73440 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2002
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
K023154 · DXC
Vascular Control Systems, Inc.
Radiology · 88d
Cleared Dec 20, 2002
DRX5000
K023160 · ITH
Axiom Usa., Inc.
Physical Medicine · 88d
Cleared Dec 20, 2002
CANDELA GENTLE YAG LASER SYSTEM
K023193 · GEX
Candela Corp.
General & Plastic Surgery · 86d
Cleared Dec 20, 2002
SYDNEY IVF HYALURONIDASE
K023353 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 74d
Cleared Dec 20, 2002
COOPERSURGICAL MALLEABLE SYTLET
K023382 · MQF
Cooper Surgical
Obstetrics & Gynecology · 73d
Cleared Dec 20, 2002
ACCESS TOTAL BHCG
K023480 · JHI
Beckman Coulter, Inc.
Chemistry · 64d
Cleared Dec 20, 2002
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
K023554 · KGI
Ge Lunar Corp.
Radiology · 58d
Cleared Dec 20, 2002
STAT PROFILE PHOX PLUS L ANALYZER
K023567 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Dec 20, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023858 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Dec 20, 2002
FLEXIMA BILIARY CATHETER
K023870 · FGE
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 30d
Cleared Dec 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883 · MEB
I-Flow Corp.
General Hospital · 29d
Cleared Dec 20, 2002
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
K023922 · HWC
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Dec 20, 2002
MODIFICATION TO MEDIPRIME
K023936 · LLZ
Algotec Systems, Ltd.
Radiology · 24d
Cleared Dec 20, 2002
VOYAGER LINUX
K023975 · HAW
Z-Kat, Inc.
Neurology · 18d
Cleared Dec 20, 2002
XTJF-160AF DUODENOVIDEOSCOPE
K024033 · FDT
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 14d
Cleared Dec 20, 2002
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
K024036 · IPF
Johari Digital Healthcare , Ltd.
Physical Medicine · 14d
Cleared Dec 20, 2002
TILITE EVO
K024055 · IOR
Tisport, LLC
Physical Medicine · 11d
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · HWC
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING,...
K024106 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 7d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING,...
K024121 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 4d
Cleared Dec 19, 2002
VIABIL BILIARY ENDOPROSTHESIS
K014215 · FGE
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 363d
Cleared Dec 19, 2002
ACELL UBM LYOPHILIZED WOUND DRESSING
K021637 · KGN
Acell, Inc.
General & Plastic Surgery · 216d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Dec 19, 2002
TRANSITIONAL IMPLANTS
K021915 · DZE
Intra-Lock International
Dental · 191d