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: 2026–2026 ×
1,642 results
649–672 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 24, 2026
PC Fix System
K260411 · HRS
Chest Wall Innovations, Inc.
Orthopedic · 74d
Cleared Apr 24, 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · HRS
Bonebridge AG
Orthopedic · 88d
Cleared Apr 24, 2026
I.T.S. PRS Phoenix II
K260054 · HRS
I.T.S. GmbH
Orthopedic · 106d
Cleared Apr 24, 2026
LungPoint Virtual Bronchoscopic Navigation (VBN) Software
K260009 · LLZ
Broncus Medical, Inc.
Radiology · 112d
Cleared Apr 24, 2026
ARTIS icono floor
K254173 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Apr 24, 2026
Dilation Balloon Catheter
K253832 · FGE
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 144d
Cleared Apr 24, 2026
Knee+
K253805 · SBF
Pixee Medical S.A.S.
Orthopedic · 147d
Cleared Apr 24, 2026
OPTIS Mobile Next Imaging System (1014932)
K253459 · NQQ
Abbott Medical
Cardiovascular · 199d
Cleared Apr 24, 2026
FloPatch FP120
K252810 · DPW
Flosonics Medical
Cardiovascular · 233d
Cleared Apr 24, 2026
Visualized Access and Delivery Catheter
K252492 · SHU
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 259d
Cleared Apr 24, 2026
EPORE® XO cup system
K252451 · OQI
Implantcast GmbH
Orthopedic · 263d
Cleared Apr 24, 2026
Elecsys Calcitonin
K252431 · JKR
Roche Diagnostics GmbH
Chemistry · 266d
Cleared Apr 24, 2026
EdgeFlow Gel Pad
K252337 · MUI
Edgecare, Inc.
Radiology · 270d
Cleared Apr 24, 2026
Diazyme Immunoglobulin A Assay
K252336
Diazyme Laboratories, Inc.
Immunology · 270d
Cleared Apr 24, 2026
Vista CMS
K250349 · MHX
Shanghai Draeger Medical Instrument...
Cardiovascular · 441d
Cleared Apr 24, 2026
Compression Therapy Device (LGT-2202DVT)
K250242 · JOW
Guangzhou Longest Medical Technology...
Cardiovascular · 452d
Cleared Apr 24, 2026
SMARTeZ™ Elastomeric Infusion Pump (RS series)
K250234 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 452d
Cleared Apr 23, 2026
OptiMap Catheter - 60mm (OPTI-CATH2-60)
K261012 · MTD
Cortex, Inc.
Cardiovascular · 27d
Cleared Apr 23, 2026
NeuroBlate System
K260976 · ONO
Monteris Medical,
Neurology · 30d
Cleared Apr 23, 2026
0.55T 12Ch Breast Coil
K260947 · MOS
Neocoil, LLC
Radiology · 31d
Cleared Apr 23, 2026
DS Core CBCT Anatomy
K260785 · QIH
Dentsply Sirona
Radiology · 44d
Cleared Apr 23, 2026
Lunit INSIGHT MMG (v1.1.10)
K260320 · QDQ
Lunit, Inc.
Radiology · 83d
Cleared Apr 23, 2026
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · DWF
Medtronic, Inc.
Cardiovascular · 91d
Cleared Apr 23, 2026
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
K260152 · EBF
Mmtech Projetos Tecnologicos...
Dental · 93d