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
17065–17088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2021
Disposable Surgical Mask
K210372 · FXX
Dongguan Shin YI Healthcare Products...
General Hospital · 119d
Cleared Jun 07, 2021
Surgical Face Mask (Ear loops and Tie-on)
K210433 · FXX
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 115d
Cleared Jun 07, 2021
Disposable Medical Mask
K210641 · FXX
Tuosheng Protective Products (Ningbo)...
General Hospital · 96d
Cleared Jun 04, 2021
Perfect EMS
K200694 · NUH
Tenscare, Ltd.
Neurology · 444d
Cleared Jun 04, 2021
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
K201309 · JXL
Mecta Corporation
Neurology · 385d
Cleared Jun 04, 2021
TruBase S
K201842 · NHA
Truabutment, Inc.
Dental · 333d
Cleared Jun 04, 2021
Kendall NPWT Incision Management Device
K202217 · OMP
Cardinalhealth
General & Plastic Surgery · 302d
Cleared Jun 04, 2021
Insulia Diabetes Management Companion
K202596 · NDC
Voluntis Sa.
Chemistry · 269d
Cleared Jun 04, 2021
Fix2Lock (PEEK Self Punching)
K202763 · MBI
Osteonic Co., Ltd.
Orthopedic · 256d
Cleared Jun 04, 2021
Surgical Green Laser System
K202828 · GEX
Realton (Suzhou) Medical Technology...
Gastroenterology & Urology · 253d
Cleared Jun 04, 2021
Disposable medical mask
K203388 · FXX
Everwin Toys (Dongguan)., Ltd.
General Hospital · 198d
Cleared Jun 04, 2021
SureStrip Vitrification Straw, SureLock Vitrification Straw
K203626 · MQK
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 175d
Cleared Jun 04, 2021
Surgical face mask
K203704 · FXX
Juntech(Jiaxing)Healthcare Materials...
General Hospital · 168d
Cleared Jun 04, 2021
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
K210014 · FLL
Guandong Genial Technology Co., Limited
General Hospital · 151d
Cleared Jun 04, 2021
Dentis s-Clean s-Line Mini
K210080 · DZE
Dentis Co., Ltd.
Dental · 143d
Cleared Jun 04, 2021
HIT Clear Aligner
K210613 · NXC
Cdb Corporation
Dental · 95d
Cleared Jun 04, 2021
Nitrile Patient Examination Gloves
K211028 · LZA
Huayuan Medical Technology(Shangqiu)...
General Hospital · 59d
Cleared Jun 04, 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · QEZ
AngioDynamics, Inc.
Cardiovascular · 53d
Cleared Jun 04, 2021
Prudent 1717, Prudent 1417, Prudent 1212
K211108 · MQB
Pixxgen Corporation
Radiology · 51d
Cleared Jun 04, 2021
Avon Patello-femoral Joint Prosthesis
K211303 · KRR
Howmedica Osteonics Corp., Dba...
Orthopedic · 36d
Cleared Jun 04, 2021
GlidePath 13F Long-Term Hemodialysis Catheter
K211410 · MSD
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 04, 2021
Micro C Medical Imaging System, M01
K211473 · IZL
Oxos Medical, Inc.
Radiology · 23d
Cleared Jun 03, 2021
PCA-C1 series Patient Cable
K200722 · DSA
QT Medical, Inc.
Cardiovascular · 441d
Cleared Jun 03, 2021
Allmed Surgical Face Masks (Ear loops)
K202128 · FXX
Allmed Medical Products Co., Ltd.
General Hospital · 307d