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
27985–28008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2017
Eztetic BellaTek Encode Healing Abutments
K170013 · NHA
Biomet 3i
Dental · 261d
Cleared Sep 21, 2017
Scanostics UTI Check Application Test System
K170118 · JMT
Teco Diagnostics
Chemistry · 251d
Cleared Sep 21, 2017
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
K170641 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 203d
Cleared Sep 21, 2017
ARIX Wrist System
K170705 · HRS
Jeil Medical Corporation
Orthopedic · 197d
Cleared Sep 21, 2017
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist...
K170879 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 181d
Cleared Sep 21, 2017
Persyst Mobile App
K171184 · OMB
Persyst Development Corporation
Neurology · 150d
Cleared Sep 21, 2017
PeriView FLEX
K171232 · KTI
Olympus Surgical Technologies America
Ear, Nose, Throat · 147d
Cleared Sep 21, 2017
Zap-X Radiosurgery System
K171804 · IYE
Zap Surgical Systems
Radiology · 94d
Cleared Sep 21, 2017
EndoNaut
K171829 · OWB
Therenva Sas
Radiology · 93d
Cleared Sep 21, 2017
DARCO Locking Bone Plate System
K171852 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 92d
Cleared Sep 21, 2017
ZS3 Ultrasound System, z.one pro Ultrasound System
K171891 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 87d
Cleared Sep 21, 2017
S60 Series Digital Color Doppler Ultrasound System
K172082 · IYN
Sonoscape Medical Corp.
Radiology · 73d
Cleared Sep 21, 2017
Mako Total Knee Application
K172219 · OLO
Mako Surgical Corp.
Orthopedic · 59d
Cleared Sep 21, 2017
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9%...
K172486 · FRO
Anexa Biomedical, Inc.
General & Plastic Surgery · 35d
Cleared Sep 21, 2017
iNSitu Total Hip System
K172501 · LPH
Theken Companies, LLC
Orthopedic · 34d
Cleared Sep 20, 2017
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K163283 · BTT
Hamilton Medical AG
Anesthesiology · 303d
Cleared Sep 20, 2017
PENTAX Medical ED34-i10T, Video Duodenoscope
K163614 · FDT
Pentax Medical
Gastroenterology & Urology · 272d
Cleared Sep 20, 2017
Tri-Ex Extraction Balloon With Multiple Sizing
K170292 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 232d
Cleared Sep 20, 2017
Powder Free Nitrile Examination Gloves (Orange)
K171541 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 117d
Cleared Sep 20, 2017
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
K171822 · NBW
Biotest Medical Corporation
Chemistry · 93d
Cleared Sep 20, 2017
Ceramill Zolid HT+ white
K171876 · EIH
Amann Girrbach AG
Dental · 89d
Cleared Sep 20, 2017
Magic3 Go Intermittent Urinary Catheter
K172247 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 56d
Cleared Sep 20, 2017
PMT Posterior Fixation System
K172279 · NKG
Providence Medical Technology, Inc.
Orthopedic · 54d
Cleared Sep 20, 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
K172314 · HQD
Art Optical Contact Lens, Inc.
Ophthalmic · 50d