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
3577–3600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2025
WiTOF
K243339 · KOI
Idmed
Anesthesiology · 241d
Cleared Jun 23, 2025
Cranial 4Pi Immobilization
K243142 · IYE
Brainlab AG
Radiology · 266d
Cleared Jun 23, 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
K242924 · NQQ
Opxion Technology, Inc.
General & Plastic Surgery · 272d
Cleared Jun 20, 2025
NovoSorb BTM
K251567 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 29d
Cleared Jun 20, 2025
FUBUKI XF-R Neurovascular Long Sheath
K251560 · QJP
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jun 20, 2025
MC2™ Two-Stage Venous Cannula
K251258 · DWF
Medtronic, Inc.
Cardiovascular · 58d
Cleared Jun 20, 2025
ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
K251248 · ITI
Jinhua Qidian Vehicle Co., Ltd.
Physical Medicine · 58d
Cleared Jun 20, 2025
Branchor X Balloon Guide Catheter
K251240 · QJP
Asahi Intecc Co., Ltd.
Neurology · 59d
Cleared Jun 20, 2025
Restrata Soft Tissue Reinforcement (STR)
K251224 · OXF
Acera Surgical, Inc.
General & Plastic Surgery · 60d
Cleared Jun 20, 2025
FloPatch FP120
K251114 · DPW
Flosonics Medical
Cardiovascular · 70d
Cleared Jun 20, 2025
PathPresenter Clinical Viewer
K250968 · QKQ
Pathpresenter Corporation
Pathology · 81d
Cleared Jun 20, 2025
LED LIGHT MASK (A093)
K250880 · OHS
Foshan Guangyu Weilai Medical...
General & Plastic Surgery · 88d
Cleared Jun 20, 2025
TMINI Miniature Robotic System
K250877 · OLO
THINK Surgical, Inc.
Orthopedic · 88d
Cleared Jun 20, 2025
Disposable Endoscopy Valve Set
K250732 · ODC
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 101d
Cleared Jun 20, 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · CAF
Hcmed Innovations Co., Ltd.
Anesthesiology · 113d
Cleared Jun 20, 2025
EsCem RMGI
K250566 · EMA
Spident Co., Ltd.
Dental · 114d
Cleared Jun 20, 2025
Us2.ca
K250151 · SDJ
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Cardiovascular · 150d
Cleared Jun 20, 2025
Incompass Total Ankle System
K250037 · HSN
Wright Medical Technology, Inc....
Orthopedic · 163d
Cleared Jun 20, 2025
LED Facial Mask
K243978 · OHS
Shenzhen Sunsred Technology Co.,Ltd
General & Plastic Surgery · 179d
Cleared Jun 20, 2025
PAL Sterilization Case
K243589 · KCT
Microaire Surgical Instruments, LLC
General Hospital · 212d
Cleared Jun 20, 2025
CT Scanner TSX-501R/1 V11.1
K243398 · JAK
Canon Medical Systems Corporation
Radiology · 232d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168 · LFX
Abbott Laboratories
Microbiology · 263d
Cleared Jun 20, 2025
HybridAPC probe
K243120 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 263d
Cleared Jun 20, 2025
BD Intelliport System
K243062 · PHC
Becton Dickinson
General Hospital · 266d