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
6241–6264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2024
InMode RF System
K240780 · GEI
Inmode , Ltd.
General & Plastic Surgery · 125d
Cleared Jul 24, 2024
Insure® Universal
K240714 · EMA
Cosmedent, Inc.
Dental · 131d
Cleared Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
K240457 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 159d
Cleared Jul 24, 2024
ExacTrac Dynamic (2.0)
K240431 · IYE
Brainlab AG
Radiology · 161d
Cleared Jul 24, 2024
CADDIE
K240044 · QNP
Odin Medical Limited
Gastroenterology & Urology · 201d
Cleared Jul 24, 2024
X-Smart Pro
K233865 · EKX
Dentsply Sirona, Inc.
Dental · 231d
Cleared Jul 24, 2024
Aptima HCV Quant Dx Assay
K233352 · MZP
Hologic, Inc.
Microbiology · 299d
Cleared Jul 24, 2024
FlexWing Anterior Cervical Plate System
K231251 · KWQ
Jeil Medical Corporation
Orthopedic · 450d
Cleared Jul 24, 2024
THE Graft Collagen
K230305 · NPM
Purgo Biologics, Inc.
Dental · 537d
Cleared Jul 23, 2024
Gaudi Proximal Humerus Plate
K241296 · HRS
Netbiologics, LLC
Orthopedic · 76d
Cleared Jul 23, 2024
EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
K241114 · LLZ
Ewoosoft Co., Ltd.
Radiology · 92d
Cleared Jul 23, 2024
TE Air Diagnostic Ultrasound System
K240906 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 112d
Cleared Jul 23, 2024
AITRICS-VC
K240756 · PLB
Aitrics Co., Ltd.
Cardiovascular · 125d
Cleared Jul 22, 2024
Kinos Total Ankle System
K241482 · HSN
Restor3d
Orthopedic · 59d
Cleared Jul 22, 2024
K-Bond Universal
K241445 · KLE
Spident Co., Ltd.
Dental · 61d
Cleared Jul 22, 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
K241119 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 90d
Cleared Jul 22, 2024
Onycho Laser V
K241116 · PDZ
Terasysd&C, Inc.
General & Plastic Surgery · 90d
Cleared Jul 22, 2024
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K240704 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 130d
Cleared Jul 22, 2024
NAVOYCDS
K240558 · PLB
Algodx AB
Cardiovascular · 145d
Cleared Jul 22, 2024
Electric Wheelchair (Robooter E60) (BBR-E60-01)
K240339 · ITI
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine · 168d
Cleared Jul 22, 2024
Maverick Diagnostic System TC1000
K234091 · JLW
Genalyte, Inc.
Chemistry · 209d
Cleared Jul 22, 2024
neo315
K231133 · LNH
Neoscan Solution GmbH
Radiology · 458d
Cleared Jul 21, 2024
PTG-05
K240347 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 167d
Cleared Jul 19, 2024
coactiv+™ Antimicrobial Wound Gel
K241809 · FRO
Kane Biotech, Inc.
General & Plastic Surgery · 28d