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
12529–12552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2022
ChoiceSpine TigerShark™ M, Modular Interbody System
K220953 · MAX
Choice Spine, LLC
Orthopedic · 165d
Cleared Sep 13, 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · NUH
Shenzhen Future Electronic Co., Ltd.
Neurology · 153d
Cleared Sep 13, 2022
P20 Elite Series Digital Color Doppler Ultrasound System
K221140 · IYN
Sonoscape Medical Corp.
Radiology · 147d
Cleared Sep 13, 2022
CLAROX plus (Model: VX-100)
K221417 · IZL
Vsi Co., Ltd.
Radiology · 120d
Cleared Sep 13, 2022
Primary Relief
K221425 · NHI
Dyansys, Inc.
Neurology · 120d
Cleared Sep 13, 2022
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
K221733 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Sep 13, 2022
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K221748 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 89d
Cleared Sep 12, 2022
SOFIA 88 Catheter
K214024 · DQY
MicroVention, Inc.
Neurology · 264d
Cleared Sep 12, 2022
Infrared Forehead Thermometer
K220084 · FLL
Qingdao Yasee Medical Device Co., Ltd.
General Hospital · 245d
Cleared Sep 12, 2022
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
K220986 · JAK
Canon Medical Systems Corporation
Radiology · 161d
Cleared Sep 12, 2022
Phosphoric Acid Etching Gel
K221450 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 117d
Cleared Sep 12, 2022
Rapid ICH
K221456 · QAS
Ischemaview, Inc.
Radiology · 116d
Cleared Sep 12, 2022
Plasma Shield
K221533 · GCJ
Plasmatica, Ltd.
General & Plastic Surgery · 108d
Cleared Sep 12, 2022
KOLO Evolution XHD Series Ultrasound Diagnostic System
K221568 · IYN
Kolo Medical (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Sep 12, 2022
Integrity-SI Fusion System
K222512 · OUR
OsteoCentric Technologies
Orthopedic · 24d
Cleared Sep 09, 2022
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set,...
K213244 · ELW
Prevest Denpro Limited
Dental · 344d
Cleared Sep 09, 2022
MICOR Lens Fragmentation System
K214028 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d
Cleared Sep 09, 2022
Dexus Prosthetics System (Model: MSL1, MSR1)
K220002 · GXY
Zhejiang Qiangnao Technology Co.,Ltd
Neurology · 248d
Cleared Sep 09, 2022
AUTOBAHN(R) EVO Femoral Nails
K220659 · HSB
Globus Medical, Inc.
Orthopedic · 186d
Cleared Sep 09, 2022
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple,...
K220859 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 169d
Cleared Sep 09, 2022
PointCore Surgical Mask
K220944 · FXX
Pointcore, Inc.
General Hospital · 162d
Cleared Sep 09, 2022
Arthrex SutureTape
K221354 · GAT
Arthrex, Inc.
General & Plastic Surgery · 122d
Cleared Sep 09, 2022
NuVasive Reline Cervical System
K221388 · NKG
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Sep 09, 2022
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature...
K222093 · MLR
Steris
General Hospital · 56d