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
19489–19512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2020
FractureDetect (FX)
K193417 · QBS
Imagen Technologies, Inc.
Radiology · 234d
Cleared Jul 30, 2020
OSSIOfiber™ Compression Screws
K193660 · HWC
OSSIO , Ltd.
Orthopedic · 213d
Cleared Jul 30, 2020
Reprocessed NRG Transseptal Needle
K200060 · QLZ
Innovative Health, LLC
Cardiovascular · 199d
Cleared Jul 30, 2020
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
K200082 · PIF
Mps Medical, Inc.
Gastroenterology & Urology · 197d
Cleared Jul 30, 2020
SpeediCath Soft
K200142 · GBM
Coloplast
Gastroenterology & Urology · 190d
Cleared Jul 30, 2020
MEDRAD Imaging Bulk Package Transfer Spike
K200280 · PQH
Bayer Medical Care, Inc.
General Hospital · 177d
Cleared Jul 30, 2020
PENTAX Medical Video Bronchoscope EB-J10 Series
K200678 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 136d
Cleared Jul 30, 2020
Safey Peak Flow Meter
K200832 · BZH
Safey Medical Devices Pvt, Ltd.
Anesthesiology · 122d
Cleared Jul 30, 2020
Safey Pocket Spirometer
K201002 · BZG
Safey Medical Devices Pvt, Ltd.
Anesthesiology · 105d
Cleared Jul 30, 2020
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
K201059 · IYN
Sonoscape Medical Corp.
Radiology · 100d
Cleared Jul 30, 2020
KY Grosz Jelly
K201186 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Jul 30, 2020
MAGEC® System
K201543 · PGN
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 51d
Cleared Jul 30, 2020
Sterispine™ PS
K201648 · NKB
Safe Orthopaedics
Orthopedic · 42d
Cleared Jul 30, 2020
Arthrex Mini Hip PushLock
K201786 · MAI
Arthrex, Inc.
Orthopedic · 30d
Cleared Jul 30, 2020
HI-TORQUE PROCEED Guide Wire Family
K201834 · DQX
Abbott Vascular
Cardiovascular · 28d
Cleared Jul 30, 2020
EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
K201851 · JWH
Corentec Co., Ltd.
Orthopedic · 24d
Cleared Jul 29, 2020
BoniPlus Dental G-Mesh System
K182759 · JEY
Montjade Engineering Co., Ltd.
Dental · 670d
Cleared Jul 29, 2020
Superpipe Angiographic Catheter
K193647 · DQO
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 212d
Cleared Jul 29, 2020
Symphony
K200413 · KGN
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 161d
Cleared Jul 29, 2020
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
K200504 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 149d
Cleared Jul 29, 2020
Pitkar External Fixation System - Rail Mechanism
K200518 · KTT
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 149d
Cleared Jul 29, 2020
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN...
K200824 · FYA
Cardinal Health200, LLC
General Hospital · 121d
Cleared Jul 29, 2020
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
K200959 · LZO
Biomet UK, Ltd.
Orthopedic · 110d
Cleared Jul 29, 2020
Bioflux Software II
K201040 · DSH
Biotricity
Cardiovascular · 119d