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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36145–36168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2014
STERILUCENT PROCESS CHALLENGE DEVICE
K141312 · FRC
Sterilucent, Inc.
General Hospital · 164d
Cleared Oct 31, 2014
IMPLANT STUDIO
K141570 · LLZ
3Shape Medical A/S
Radiology · 141d
Cleared Oct 31, 2014
NAWALUTION SKIN AND WOUND CLEANSER
K141660 · FRO
Nawa Heilmittel GmbH
General & Plastic Surgery · 133d
Cleared Oct 31, 2014
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K141700 · MUH
Genoray Co., Ltd.
Radiology · 129d
Cleared Oct 31, 2014
IQQA-BODYIMAGING SOFTWARE
K141745 · LLZ
Edda Technology
Radiology · 123d
Cleared Oct 31, 2014
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 123d
Cleared Oct 31, 2014
RAPIDRESULTS
K141881 · LLZ
Ramsoft, Inc.
Radiology · 112d
Cleared Oct 31, 2014
SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE,...
K141941 · OLO
Stryker Corporate
Orthopedic · 106d
Cleared Oct 31, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
K142088 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 91d
Cleared Oct 31, 2014
NS3000 Holmium Laser System
K142286 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 74d
Cleared Oct 31, 2014
Sternal Closure System
K142484 · HRS
Jace Medical, LLC
Orthopedic · 57d
Cleared Oct 31, 2014
SoftVue
K142517 · IYO
Delphinus Medical Technologies, Inc.
Radiology · 53d
Cleared Oct 31, 2014
Bard RiteCath Intermittent Urinary Catheter
K142575 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 30, 2014
NOVAPACS
K132853 · LLZ
Novarad Corp.
Radiology · 413d
Cleared Oct 30, 2014
VC150 VITAL SIGNS MONITOR
K133810 · MWI
Innokas Yhtyma
Cardiovascular · 318d
Cleared Oct 30, 2014
KJ EXTERNAL IMPLANT SYSTEM
K140051 · DZE
Kj Meditech Co., Ltd.
Dental · 294d
Cleared Oct 30, 2014
J2I IMPLANT SYSTEM
K140052 · DZE
Kj Meditech Co., Ltd.
Dental · 294d
Cleared Oct 30, 2014
ELIA SCL-70S IMMUNOASSAY
K140493 · LJM
Phadia GmbH
Immunology · 245d
Cleared Oct 30, 2014
ASTROGLIDE SENSUAL STRAWBERRY
K140590 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 237d
Cleared Oct 30, 2014
VELASII THERAPY LASER SYSTEM
K142078 · ILY
Aspen Laser Systems, LLC
Physical Medicine · 91d
Cleared Oct 30, 2014
ISO-GARD MASK
K142138 · CBN
Teleflexmedical, Inc.
Anesthesiology · 86d
Cleared Oct 30, 2014
Pico Way Laser System
K142372 · GEX
Candela Corpation
General & Plastic Surgery · 66d
Cleared Oct 30, 2014
Miltex N-Tralig Intraligamentary Syringe
K142414 · EJI
Integra LifeSciences Corporation
Dental · 63d
Cleared Oct 30, 2014
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
K142443 · IYO
C.R. Bard, Inc.
Radiology · 58d