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
25–48 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Oct 02, 2026
Ventricular Catheters, Thomale Catheter
K260044 · JXG
Aesculap, Inc.
Neurology · 268d
Cleared Oct 02, 2026
cCeLL405
K254030 · QFX
VPIX Medical, Inc.
Neurology · 290d
Cleared Oct 02, 2026
OAB Delivery Catheter
K253422 · QJP
Cognition Medical Corp.
Neurology · 366d
Cleared Oct 01, 2026
Dual Stage Venous Cannulae
K263092 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Oct 01, 2026
NOVIX Pedicle Screw System
K263062 · NKB
Tdm Co., Ltd.
Orthopedic · 30d
Cleared Oct 01, 2026
Intra-Operative Positioning System (IOPS) and IOPS Visionary System
K263016 · DQK
Centerline Biomedical
Cardiovascular · 34d
Cleared Oct 01, 2026
NEXUS® Hip Stem
K262473 · LZO
Microport Orthopedics, Inc.
Orthopedic · 76d
Cleared Oct 01, 2026
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low...
K262208 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 93d
Cleared Oct 01, 2026
SwiftSight-BodyComposition
K261612 · LNH
Airs Medical, Inc.
Radiology · 139d
Cleared Oct 01, 2026
Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C,...
K260470 · DXN
Shenzhen Brav Electronic Technologies...
Cardiovascular · 231d
Cleared Oct 01, 2026
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
K260283 · LON
bioMerieux, Inc.
Microbiology · 245d
Cleared Oct 01, 2026
Firstar Dental Handpieces
K260029 · EFB
FDC Technology Industry Co.
Dental · 269d
Cleared Oct 01, 2026
Firstar Dental Electric Motor
K260027 · EBW
FDC Technology Industry Co.
Dental · 269d
Cleared Sep 30, 2026
SAS MIS Pelvic Incidence Rods
K263172 · NKB
Spinal Alignment Solutions, Inc.
Orthopedic · 20d
Cleared Sep 30, 2026
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes...
K263035 · OZE
Centers For Disease Control and...
Microbiology · 30d
Cleared Sep 30, 2026
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3)...
K263033 · OAS
Fussen Technology Co., Ltd.
Radiology · 30d
Cleared Sep 30, 2026
Eonis™ SMA kit
K262893 · QUE
Revvity, Inc.
Chemistry · 44d
Cleared Sep 30, 2026
Duet™ Spinal Fixation System
K262712 · NKB
Duet Spine Holdings, LLC
Orthopedic · 61d
Cleared Sep 30, 2026
Rapid Barostat Bag (RBB) Pump and Catheter System
K262621 · FFX
Mui Scientific, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 30, 2026
Spine Planning (3.0)
K262257 · OLO
Brainlab SE
Orthopedic · 90d
Cleared Sep 30, 2026
danumed StomaMeter
K262038 · KNT
Danumed Medizintechnik GmbH
Gastroenterology & Urology · 105d
Cleared Sep 30, 2026
Braun Aura 7 (6041)
K261975 · OHT
Cyden Limited
General & Plastic Surgery · 110d
Cleared Sep 30, 2026
EzSensor HD
K261663 · MUH
Qpix Solutions, Inc.
Radiology · 133d
Cleared Sep 30, 2026
Nexxis 2
K261469 · DXJ
Barco N.V.
General & Plastic Surgery · 149d