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: 2026–2026 ×
1,922 results
1897–1920 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 07, 2026
ZenSeal Pro
K252890 · KIF
Kerr Corporation
Dental · 118d
Cleared Jan 07, 2026
Neodent InLab Validated Workflow
K252727 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 132d
Cleared Jan 07, 2026
SmileInspector
K252507 · PNN
Amv Consulting, LLC
Dental · 152d
Cleared Jan 07, 2026
Clear Aligner (SCF-3348)
K251454 · NXC
Beame Medical Technology (Shenzhen)...
Dental · 240d
Cleared Jan 07, 2026
Sangria™ Thrombectomy System
K251207 · QEW
Avantec Vascular Corporation
Cardiovascular · 264d
Cleared Jan 07, 2026
Reprocessed Agilis NxT Steerable Introducer
K250305 · PNE
Innovative Health
Cardiovascular · 338d
Cleared Jan 06, 2026
Materialise TKA Guide System
K253793 · JWH
Materialise NV
Orthopedic · 39d
Cleared Jan 06, 2026
QuadLock™ Fixation System
K253618 · MBI
Abanza Tecnomed S.L
Orthopedic · 49d
Cleared Jan 06, 2026
TRILEAP Plating System
K253178 · HRS
Crossroads Extremity Systems
Orthopedic · 102d
Cleared Jan 06, 2026
aprevo® cervical interbody system
K252894 · ODP
Carlsmed, Inc.
Orthopedic · 117d
Cleared Jan 06, 2026
Pen Needle
K252886 · FMI
Hh Global Technology, Inc.
General Hospital · 118d
Cleared Jan 06, 2026
Medconn 8K Glycated Hemoglobin Test System
K252749 · PDJ
Shanghai Medconn Medical Technology...
Chemistry · 130d
Cleared Jan 06, 2026
Saans (F4-01-00-000-000)
K251165 · SGR
Innaccel Technologies Private Limited
Anesthesiology · 266d
Cleared Jan 06, 2026
V-DAC Catheter
K251097 · QJP
Vesalio, Inc.
Neurology · 271d
Cleared Jan 06, 2026
Sensilift Pro (ST300XXYYZZZ)
K250341 · PAY
El Global Trade, Ltd.
General & Plastic Surgery · 334d
Cleared Jan 05, 2026
maiLink
K253008 · LLZ
Maihub Corp.
Radiology · 108d
Cleared Jan 05, 2026
ChartCheck (RADCH V1.6)
K252988 · IYE
Radformation, Inc.
Radiology · 109d
Cleared Jan 05, 2026
Disposable Medical Face Mask
K252650 · FXX
Makrite Industries, Inc.
General Hospital · 136d
Cleared Jan 05, 2026
HERA Z20 Diagnostic Ultrasound System
K252018 · IYN
Samsung Medison Co., Ltd.
Radiology · 189d
Cleared Jan 05, 2026
Puracyn® Plus Antimicrobial Irrigation Solution
K251757 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 210d
Cleared Jan 05, 2026
SurfRider 13 Microcatheter
K251668 · QJP
Kaneka Americas Holding, Inc.
Neurology · 220d
Cleared Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
K251630 · LTJ
Siemens Healthcare Diagnostics, Inc.
Immunology · 222d
Cleared Jan 02, 2026
FiberLocker Implant
K253867 · OWX
ZuriMED Technologies AG
Orthopedic · 30d
Cleared Jan 02, 2026
MONTAGE XT Cranial Cement
K253854 · GXP
Orthocon, Inc.
Neurology · 30d