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
7225–7248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2024
ProSeal™ Injector Plus (Model no. 421050)
K240171 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 66d
Cleared Mar 28, 2024
Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration...
K233909 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 107d
Cleared Mar 28, 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
K233838 · NEY
Medtronic, Inc.
General & Plastic Surgery · 115d
Cleared Mar 28, 2024
FDR Visionary Suite
K233719 · KPR
Shimadzu Corporation
Radiology · 128d
Cleared Mar 28, 2024
OEC 3D
K233669 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 134d
Cleared Mar 28, 2024
NAEOTOM Alpha
K233657 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 135d
Cleared Mar 28, 2024
CORE 500 Digital Stethoscope
K233609 · DQD
Eko Health, Inc.
Cardiovascular · 136d
Cleared Mar 28, 2024
BTL-785S
K233604 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 140d
Cleared Mar 28, 2024
Eko Low Ejection Fraction Tool (ELEFT)
K233409 · QYE
Eko Health, Inc.
Cardiovascular · 174d
Cleared Mar 28, 2024
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use...
K232079 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 259d
Cleared Mar 28, 2024
IS-III active Short Implant
K232049 · DZE
Neobiotech Co., Ltd.
Dental · 262d
Cleared Mar 28, 2024
VIVACE
K232047 · HGX
Unimom.Co
Obstetrics & Gynecology · 262d
Cleared Mar 28, 2024
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040,...
K232013 · PNO
Goodman Co., Ltd.
Cardiovascular · 266d
Cleared Mar 28, 2024
Advanta VXT Vascular Graft, Flixene Vascular Graft
K231972 · DSY
Atrium Medical Corporation
Cardiovascular · 269d
Cleared Mar 27, 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
K240389 · NEW
Hyundae Meditech Co., Ltd.
General & Plastic Surgery · 48d
Cleared Mar 27, 2024
QStat Cartridge
K240045 · QFR
Hemosonics, LLC
Hematology · 82d
Cleared Mar 27, 2024
Lucent® XP
K234150 · MAX
Spinal Elements
Orthopedic · 89d
Cleared Mar 27, 2024
i-STAT TBI Cartridge with the i-STAT Alinity System
K234143 · QAT
Abbott Point of Care
Immunology · 89d
Cleared Mar 27, 2024
Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested...
K234097 · LZA
Ever Growth (Vietnam) Corporation...
General Hospital · 92d
Cleared Mar 27, 2024
CarboClear® Posterior Cervical Screw System
K233989 · NKG
CarboFix Orthopedics , Ltd.
Orthopedic · 100d
Cleared Mar 27, 2024
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
K233951 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared Mar 27, 2024
MAMMOMAT B.brilliant
K233539 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 145d
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201 · QJP
Penumbra, Inc.
Neurology · 181d
Cleared Mar 27, 2024
CARPL (CARPL)
K232891 · LLZ
Carpl Ai, Inc.
Radiology · 191d