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
17785–17808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2021
Cultura Collection and Transport System
K201674 · JSM
Merit Medical Systems, Inc.
Microbiology · 257d
Cleared Mar 03, 2021
Medical mask (Model: KKF-1A)
K202316 · FXX
Han Zhaoqing Sporting Goods Company...
General Hospital · 198d
Cleared Mar 03, 2021
Promaxo MRI System
K202518 · LNH
Promaxo, Inc.
Radiology · 183d
Cleared Mar 03, 2021
EOGas 4 Endo-SteriTest RRBI
K202879 · FRC
Andersen Sterilizers, Inc.
General Hospital · 156d
Cleared Mar 03, 2021
FineCross M3
K203521 · DQY
Ashitaka Factory of Terumo Corporation
Cardiovascular · 92d
Cleared Mar 03, 2021
FORZA Ti Spacer System
K203576 · MAX
Orthofix, Inc.
Orthopedic · 86d
Cleared Mar 03, 2021
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T...
K203764 · QJP
Imperative Care, Inc.
Neurology · 70d
Cleared Mar 03, 2021
Ponto Bone Anchored Hearing System, MONO Surgery Kit
K203807 · MAH
Oticon Medical AB
Ear, Nose, Throat · 65d
Cleared Mar 03, 2021
LOQTEQ Distal Lateral Femur Plate 4.5 System
K210043 · HRS
Aap Implantate AG
Orthopedic · 55d
Cleared Mar 03, 2021
Biograph Vision Quadra PET/CT System
K210262 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Mar 03, 2021
3M Attest Rapid Readout Biological Indicator, 1295
K210277 · FRC
3M Company
General Hospital · 30d
Cleared Mar 03, 2021
Geistlich Mucograft®, Geistlich Mucograft® Seal
K210280 · NPL
Geistlich Pharma AG
Dental · 30d
Cleared Mar 03, 2021
WIRION Embolic Protection System
K210282 · NTE
Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Mar 03, 2021
AtriClip LAA Exclusion System
K210293 · PZX
AtriCure, Inc.
Cardiovascular · 29d
Cleared Mar 03, 2021
Mars 1417X Wireless Digital Flat Panel Detector
K210316 · MQB
Iray Technology Taicang , Ltd.
Radiology · 28d
Cleared Mar 02, 2021
Arisure Closed System Drug Transfer Device (CSTD)
K201422 · ONB
Yukon Medical, LLC
General Hospital · 277d
Cleared Mar 02, 2021
Surgical Mask-Model Number: Ear Loop, Flat-Pleated
K201852 · FXX
Huizhou Foryou Medical Devices Co., Ltd.
General Hospital · 239d
Cleared Mar 02, 2021
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G...
K201965 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 230d
Cleared Mar 02, 2021
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
K202113 · JFB
Ceragem Co., Ltd.
Physical Medicine · 215d
Cleared Mar 02, 2021
Senhance Surgical System
K202166 · NAY
Transenterix, Inc.
General & Plastic Surgery · 211d
Cleared Mar 02, 2021
IFM Surgical Mask Model SM3
K202214 · FXX
Fssc, LLC
General Hospital · 208d
Cleared Mar 02, 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
K202356 · LZA
Kanglongda Vietnam Protection...
General Hospital · 195d
Cleared Mar 02, 2021
Able Medical Devices Valkyrie Thoracic Fixation System
K202889 · HRS
Jm Longyear Manufacturing, LLC D.B.A....
Orthopedic · 155d
Cleared Mar 02, 2021
X-PLO2R
K203086 · CAW
Belluscura, LLC
Anesthesiology · 140d