FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
26737–26760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2018
Digitex Delivery Device
K173527 · PWI
Coloplast A/S
Obstetrics & Gynecology · 90d
Cleared Feb 12, 2018
Vinyl Patient Examination Glove (Yellow)
K173561 · LYZ
Yurun Glove Co., Ltd.
General Hospital · 87d
Cleared Feb 12, 2018
Thorecon™ Fixation System
K173579 · JDQ
A & E Medical Corporation
Orthopedic · 84d
Cleared Feb 12, 2018
CELERITY 20 Steam Biological Indicator
K173634 · FRC
STERIS Corporation
General Hospital · 80d
Cleared Feb 12, 2018
CELERITY 20 Steam Incubator
K173670 · FRC
STERIS Corporation
General Hospital · 74d
Cleared Feb 12, 2018
MotoBAND CP Implant System
K173710 · HWC
Crossroads Extremity Systems, LLC
Orthopedic · 70d
Cleared Feb 12, 2018
Arthrex NanoSuture Anchor
K180118 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared Feb 11, 2018
geko T-2 and geko Plus R-2
K180082 · IPF
Firstkind, Ltd.
Physical Medicine · 31d
Cleared Feb 10, 2018
TAV Medical Dental Implants System
K170131 · DZE
Tav Medical , Ltd.
Dental · 389d
Cleared Feb 09, 2018
BR Type Implant System
K171179 · DZE
Biotem Co., Ltd.
Dental · 291d
Cleared Feb 09, 2018
AT-6XX Series Infrared Thermometer
K171455 · FLL
Xiamen Acurio Instruments Co., Ltd.
General Hospital · 268d
Cleared Feb 09, 2018
Standard Catheter Set
K171631 · JAQ
Varian Medical Systems, Inc.
Radiology · 252d
Cleared Feb 09, 2018
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy...
K171755 · OWB
Omega Medical Imaging, LLC
Radiology · 241d
Cleared Feb 09, 2018
Southern Implants PEEK Abutments
K172160 · NHA
Southern Implants (Pty), Ltd.
Dental · 206d
Cleared Feb 09, 2018
OSCAR 15
K172180 · OWB
Genoray Co., Ltd.
Radiology · 205d
Cleared Feb 09, 2018
NAPA LP-15 Airway Pressure Monitor
K172284 · CAP
Drw Medical, LLC
Anesthesiology · 196d
Cleared Feb 09, 2018
Kohli Urinary Drainage Catheter
K172422 · EZL
Nellie Medical, LLC
Gastroenterology & Urology · 183d
Cleared Feb 09, 2018
Tosama Biobased Applicator Tube Menstrual Tampon
K172504 · HEB
Tosama, D.O.O.
Obstetrics & Gynecology · 175d
Cleared Feb 09, 2018
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator...
K172746 · JOJ
STERIS Corporation
General Hospital · 150d
Cleared Feb 09, 2018
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological...
K172748 · FRC
Steris Corporations
General Hospital · 150d
Cleared Feb 09, 2018
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K172749 · FRG
STERIS Corporation
General Hospital · 150d
Cleared Feb 09, 2018
iVitri Straw
K172751 · MQK
Reprobitech Corp.
Obstetrics & Gynecology · 150d
Cleared Feb 09, 2018
CELERITY 20 HP Biological Indicator
K172752 · FRC
STERIS Corporation
General Hospital · 150d
Cleared Feb 09, 2018
VERIFY VH2O2 Indicator Tape
K172753 · JOJ
STERIS Corporation
General Hospital · 150d