FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
10369–10392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2023
Bronchoscope System
K222910 · EOQ
Shenzhen HugeMed Medical Technical...
Ear, Nose, Throat · 197d
Cleared Apr 11, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
K223530 · NRY
Route 92 Medical, Inc.
Neurology · 139d
Cleared Apr 11, 2023
ZeptoLink IOL Positioning System
K223763 · PUL
Centricity Vision, Inc.
Ophthalmic · 117d
Cleared Apr 11, 2023
Ultrasound System 2300
K223830 · IYN
Bk Medical Aps
Radiology · 111d
Cleared Apr 11, 2023
ENROUTE® Transcarotid Neuroprotection System
K230402 · NTE
Silk Road Medical
Cardiovascular · 55d
Cleared Apr 11, 2023
POT PTCA Balloon Dilatation Catheter
K230705 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 28d
Cleared Apr 11, 2023
Eagle S/Saevo Slim/D700 Slim
K230732 · MUH
Alliage S/A Industrias Medica...
Radiology · 26d
Cleared Apr 11, 2023
RCT800
K230753 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Apr 11, 2023
L12 LED Light Source with AIM
K230754 · OWN
Stryker
General & Plastic Surgery · 25d
Cleared Apr 10, 2023
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
K222887 · DXN
Famidoc Technology Company Limited
Cardiovascular · 199d
Cleared Apr 10, 2023
Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner...
K223176 · KRA
Argon Medical Devices, Inc.
Cardiovascular · 181d
Cleared Apr 10, 2023
DMX
K223550 · KPR
Del Medical, Inc.
Radiology · 136d
Cleared Apr 10, 2023
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
K230122 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 83d
Cleared Apr 10, 2023
TENS and EMS Stimulation (OTC)
K230164 · NUH
Changsha Yuwen Medical Equipment Co.,...
Physical Medicine · 80d
Cleared Apr 10, 2023
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
K230360 · OHT
Shenzhen Jizhimei Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Apr 10, 2023
Arthrex Univers Revers Monoblock Stem Size 4/33
K230366 · PHX
Arthrex, Inc.
Orthopedic · 59d
Cleared Apr 10, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K230695 · NRY
Alembic, LLC
Neurology · 28d
Cleared Apr 10, 2023
ARIA Radiation Therapy Management (v18.0)
K230699 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Apr 07, 2023
Elecsys FT4 IV
K220456 · CEC
Roche Diagnostics
Chemistry · 414d
Cleared Apr 07, 2023
Axiostat Gauze
K222909 · QSY
Advamedica, Inc.
General & Plastic Surgery · 193d
Cleared Apr 07, 2023
Peri-Guard and Supple Peri-Guard
K223052 · FTM
Synovis Life Technologies, Inc.
General & Plastic Surgery · 190d
Cleared Apr 07, 2023
BD SmartSite™ Needle-Free Connector
K223088 · FPA
Care Fusion
General Hospital · 189d
Cleared Apr 07, 2023
Enivo™
K223373 · BTA
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 154d
Cleared Apr 07, 2023
Axoguard HA+ Nerve Protector (AGHA12)
K223640 · JXI
Axogen Corporation
Neurology · 123d