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
28825–28848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2017
C-Line Orthodontic Ceramic Bracket
K163467 · NJM
Biocetec Co., Ltd.
Dental · 184d
Cleared Jun 14, 2017
BodyTom Elite
K170238 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 139d
Cleared Jun 14, 2017
MAGNETOM Vida
K170396 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Jun 14, 2017
EVOS Small Fragment Lower Extremity Plates
K170457 · HRS
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 14, 2017
EchoPAC Software Only, EchoPAC Plug-in
K170847 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 86d
Cleared Jun 14, 2017
Alzair Allergy Blocker
K170848 · NUP
Nasaleze International, Ltd.
Ear, Nose, Throat · 85d
Cleared Jun 14, 2017
Vivid S60N, Vivid S70N
K170878 · IYN
GE Medical Systems Ultrasound &...
Radiology · 82d
Cleared Jun 14, 2017
TONOPORT VI
K170966 · DXN
Par Medizintechnik GmbH & Co. KG
Cardiovascular · 75d
Cleared Jun 14, 2017
Endoform Topical Matrix
K171231 · KGN
Aroa Biosurgery
General & Plastic Surgery · 48d
Cleared Jun 14, 2017
hema-screen SPECIFIC Gold
K171484 · KHE
Immunostics Inc.,
Hematology · 23d
Cleared Jun 13, 2017
COOK Vacuum Pump
K160753 · MQG
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 452d
Cleared Jun 13, 2017
Deep Conical (DC) Implants and Accessories
K163060 · DZE
Southern Implants (Pty), Ltd.
Dental · 224d
Cleared Jun 13, 2017
HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and...
K163079 · ILY
Healthlight, LLC
Physical Medicine · 222d
Cleared Jun 13, 2017
SECRET RF
K170325 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 131d
Cleared CT Jun 13, 2017
da Vinci Xi Surgical System
K170713 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 96d
Cleared Jun 13, 2017
Sculpsure
K171111 · PKT
Cynosure, Inc.
General & Plastic Surgery · 60d
Cleared Jun 13, 2017
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
K171426 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Jun 13, 2017
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
K171427 · OTD
Medtronic Vascular, Inc.
Cardiovascular · 29d
Cleared Jun 13, 2017
FUSE Spinal System
K171468 · MAX
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Jun 12, 2017
MELODY, Remote Control System for Ultrasound Probe
K161354 · IYO
Adecho Tech
Radiology · 392d
Cleared Jun 12, 2017
SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon...
K162625 · LOX
B. Braun Interventional Systems, Inc.
Cardiovascular · 265d
Cleared Jun 12, 2017
Picocare
K162755 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 255d
Cleared Jun 12, 2017
SPIRA Open Matrix ALIF
K162986 · MAX
Camber Spine Technologies
Orthopedic · 228d
Cleared Jun 12, 2017
Vivid E80, Vivid E90, Vivid E95
K170823 · IYN
GE Medical Systems Ultrasound and...
Radiology · 84d