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
29713–29736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2017
VIVA combo RF System
K163450 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 90d
Cleared Mar 08, 2017
OrthoSolutions 'System26' Bone Screws
K163489 · HWC
Ortho Solutions UK Limited
Orthopedic · 86d
Cleared Mar 08, 2017
VersaOne fascial closure system bladed trocar, VersaOne fascial closure...
K163654 · GCJ
Covidien, LLC
General & Plastic Surgery · 75d
Cleared Mar 08, 2017
Vial2Bag Direct Connect
K170095 · LHI
Medimop Medical Project , Ltd.
General Hospital · 56d
Cleared Mar 08, 2017
Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency...
K170188 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 44d
Cleared Mar 07, 2017
RenovoCath
K160067 · MJN
Renovorx, Inc.
Cardiovascular · 419d
Cleared Mar 07, 2017
Vado Steerable Sheath
K160721 · DYB
Kalila Medical, Inc.
Cardiovascular · 356d
Cleared Mar 07, 2017
iSage Rx (iSage Rx Basal Insulin Titration)
K161865 · NDC
Isag Rx, Inc.
General Hospital · 243d
Cleared Mar 07, 2017
Straumann PrefGel
K162311 · KJJ
Institut Straumann AG
Dental · 201d
Cleared Mar 07, 2017
CIMLRE F1 and CIMILRE S3
K162870 · HGX
Cimilre Co., Ltd.
Obstetrics & Gynecology · 145d
Cleared Mar 07, 2017
Flexi-Seal PROTECT Fecal Management System
K162906 · KNT
Convatec
Gastroenterology & Urology · 141d
Cleared Mar 07, 2017
Male Latex Condoms
K162919 · HIS
Zhejiang Xiangban Latex Products Co.,...
Obstetrics & Gynecology · 140d
Cleared Mar 07, 2017
PRECICE Intramedullary Limb Lengthening System
K170346 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 33d
Cleared Mar 07, 2017
CenterCross Ultra LV Catheter
K170403 · DQY
Roxwood Medical, Inc.
Cardiovascular · 26d
Cleared Mar 06, 2017
SALVATION External Fixation System
K162033 · KTT
Wright Medical
Orthopedic · 227d
Cleared Mar 06, 2017
GMK Sphere
K162035 · JWH
Medacta International S.A.
Orthopedic · 227d
Cleared Mar 06, 2017
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse...
K162325 · PHX
Exactech, Inc.
Orthopedic · 199d
Cleared Mar 06, 2017
Next Science Wound Gel (Rx)
K163188 · FRO
Next Science, LLC
General & Plastic Surgery · 112d
Cleared Mar 06, 2017
Greiner Vacuette Urine Count and Culture, Mannitol tube
K163436 · JSM
Greiner Bio-One Na, Inc.
Microbiology · 89d
Cleared Mar 06, 2017
TSolution One Surgical System Model 210
K170430 · OLO
THINK Surgical, Inc.
Orthopedic · 21d
Cleared Mar 03, 2017
Glass Ionomer Cement
K160345 · EMA
Shandong Huge Dental Material...
Dental · 389d
Cleared Mar 03, 2017
SREE MRI Transport Incubator
K161918 · FPL
Advanced Imaging Research Dba Sree...
General Hospital · 233d
Cleared Mar 03, 2017
Curasite
K161991 · FRO
Izun Pharmaceuticals
General & Plastic Surgery · 227d
Cleared Mar 03, 2017
Dentca Denture Base II
K162044 · EBI
Dentca, Inc.
Dental · 221d