FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
1–24 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Oct 02, 2026
Xpert Xpress CoV-2/Flu plus
K263120 · QOF
Cepheid
Microbiology · 28d
Cleared Oct 02, 2026
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
K263116 · HWC
OsteoCentric Technologies
Orthopedic · 28d
Cleared Oct 02, 2026
ZSAlign Cervical Interbody System
K263113 · OVE
Zsfab, Inc.
Orthopedic · 28d
Cleared Oct 02, 2026
AltiVate Reverse® Glenosphere with RAVN™ Technology
K263086 · PHX
Encore Medical, L.P.
Orthopedic · 30d
Cleared Oct 02, 2026
Response Ortho Smart Fixator - Hexapod System
K263083 · KTT
Response Ortho Solutions, LLC
Orthopedic · 30d
Cleared Oct 02, 2026
Medical Monitor (32MD08WC)
K262985 · PGY
Lg Electronics.Inc
Radiology · 36d
Cleared Oct 02, 2026
Coronis Fusion 4MP (MDCC-4630)
K262412 · PGY
Barco NV
Radiology · 79d
Cleared Oct 02, 2026
REMEX-T(K)100C
K261943 · IZL
Remedi, Inc.
Radiology · 114d
Cleared Oct 02, 2026
Voluson Expert 18
K261933 · IYN
GE Medical Systems Ultrasound and...
Radiology · 115d
Cleared Oct 02, 2026
MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor
K261791 · FEB
Steris
General Hospital · 126d
Cleared Oct 02, 2026
Plenity-V (MC0979 / GS110)
K261783 · QFQ
Gelesis SRL
Gastroenterology & Urology · 126d
Cleared Oct 02, 2026
Hemostatic Clip
K261741 · PKL
Anrei Medical (Hz) Co., Ltd.
Gastroenterology & Urology · 128d
Cleared Oct 02, 2026
TDM Large Bone Plate and Screw System
K261611 · HRS
Tdm Co., Ltd.
Orthopedic · 140d
Cleared Oct 02, 2026
Minuteman G6 MIS Fusion Plate
K261607 · PEK
Spinal Simplicity, LLC
Orthopedic · 141d
Cleared Oct 02, 2026
AnyPlus II Spinal Fixation System
K261217 · NKB
GS Medical Co., Ltd.
Orthopedic · 171d
Cleared Oct 02, 2026
Lung Guidance
K261042 · QJU
GE Medical Systems Ultrasound &...
Radiology · 185d
Cleared Oct 02, 2026
CVS Advanced PLUS Blood Glucose Monitoring System
K260689 · NBW
I-Sens, Inc.
Chemistry · 213d
Cleared Oct 02, 2026
Ninenovo Blood Oxygen Ring...
K260490 · DQA
Shenzhen Ninenovo Technology Limited
Anesthesiology · 231d
Cleared Oct 02, 2026
stentFIX System Set (100.50n)
K260487 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 231d
Cleared Oct 02, 2026
H100Plus Hemoglobin Testing System
K260468 · PDJ
Shenzhen Lifotronic Technology Co., Ltd.
Chemistry · 232d
Cleared Oct 02, 2026
Elecsys EBV IgM
K260233 · LJN
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Elecsys EBV VCA IgG
K260232 · LSE
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Elecsys EBV EBNA IgG
K260221 · LSE
Roche Diagnostics
Microbiology · 249d
Cleared Oct 02, 2026
Neurora
K260064 · QPF
Argus Cognitive, Inc.
Neurology · 266d