FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10657–10680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 07, 2023
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
K223772 · HRS
Stryker GmbH
Orthopedic · 112d
Cleared Apr 07, 2023
Dental CT Scanner AXR
K223816 · OAS
Alliage S/A Industrias Medico...
Radiology · 108d
Cleared Apr 07, 2023
Mazor X System (Mazor X Stealth Edition)
K230064 · OLO
Mazor Robotics , Ltd.
Orthopedic · 88d
Cleared Apr 07, 2023
Memo 3D Semirigid Annuloplasty Ring
K230318 · KRH
Corcym S.r.l.
Cardiovascular · 60d
Cleared Apr 07, 2023
Limbus Contour
K230575 · LLZ
Limbus Ai, Inc.
Radiology · 37d
Cleared Apr 07, 2023
SKOUT® system
K230658 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 06, 2023
RayFlow
K222023 · DQY
Hexacath
Cardiovascular · 269d
Cleared Apr 06, 2023
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
K222197 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 258d
Cleared Apr 06, 2023
AI-Rad Companion (Cardiovascular)
K222360 · JAK
Siemens Medical Solutions U.S.A.
Radiology · 245d
Cleared Apr 06, 2023
Disposable Insulin Pen Needle
K222739 · FMI
Hantech Medical Device Co., Ltd.
General Hospital · 209d
Cleared Apr 06, 2023
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700...
K223458 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 141d
Cleared Apr 06, 2023
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19,...
K223531 · MHX
GE Healthcare Finland Oy
Cardiovascular · 134d
Cleared Apr 06, 2023
Contour ProtégéAI
K223774 · QKB
Mim Software, Inc.
Radiology · 111d