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
1801–1824 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 16, 2026
FL-10000U Respiratory Humidifier
K251448 · BTT
Flexicare Medical Limited.
Anesthesiology · 252d
Cleared Jan 16, 2026
OptoMonitor 3
K251367 · DXO
Opsens, Inc.
Cardiovascular · 260d
Cleared Jan 16, 2026
Eyer 2
K251353 · HKI
Phelcom Technologies
Ophthalmic · 261d
Cleared Jan 16, 2026
VITAL Tubing Sets for Hemodialysis
K251341 · FJK
Vital Healthcare Sdn. Bhd.
Gastroenterology & Urology · 261d
Cleared Jan 16, 2026
Tru Hematology Test
K251249 · GKZ
Truvian Sciences, Inc.
Hematology · 268d
Cleared Jan 16, 2026
WAVE Clinical Platform (2.0.000)
K250135 · MWI
Baxter Healthcare Corp/ Excel Medical
Cardiovascular · 364d
Not Cleared Jan 16, 2026
Sana Device
DEN250005 · QYN
Sana Health
Neurology · 319d
Cleared Jan 15, 2026
Curiteva Porous PEEK Cervical Interbody Fusion System
K254061 · ODP
Curiteva, Inc.
Orthopedic · 29d
Cleared Jan 15, 2026
TriMed Volar Bearing Plates (VBEAL-13-7S)
K254002 · HRS
TriMed, Inc.
Orthopedic · 31d
Cleared Jan 15, 2026
Aventus Thrombectomy System
K253925 · QEZ
Inquis Medical
Cardiovascular · 38d
Cleared Jan 15, 2026
MiniMed 780G Insulin Pump (MMT-1884)
K253470 · QFG
Medtronic Minimed, Inc.
Chemistry · 97d
Cleared Jan 15, 2026
Electric Wheelchair (Robooter E80) (BBR-E80-01)
K253276 · ITI
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine · 108d
Cleared Jan 15, 2026
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
K253171 · LZO
Maxx Orthopedics, Inc.
Orthopedic · 111d
Cleared Jan 15, 2026
BIOGRAPH One
K253023 · OUO
Siemens Healthineers AG
Radiology · 118d
Cleared Jan 15, 2026
Diagnocat
K252934 · MYN
DGNCT, LLC
Radiology · 122d
Cleared Jan 15, 2026
AltiVate Reverse® ADLC Glenosphere
K252567 · PHX
Encore Medical, L.P.
Orthopedic · 154d
Cleared Jan 15, 2026
N22 EZ Glenosphere
K252516 · PHX
Shoulder Innovations, Inc.
Orthopedic · 157d
Cleared Jan 15, 2026
Nano-Check Influenza A+B Test
K252283 · PSZ
Nano-Ditech Corporation
Microbiology · 177d
Cleared Jan 15, 2026
EMLA (Elekta Evo)
K252188 · IYE
Elekta Solutions AB
Radiology · 185d
Cleared Jan 15, 2026
SDS Growing Rod
K251961 · PGM
BAAT Medical Products B.V.
Orthopedic · 203d
Cleared Jan 15, 2026
Sleepnet Arie Full Face Vented Mask
K251847 · BZD
Sleepnet Corporation
Anesthesiology · 213d
Cleared Jan 15, 2026
Bio-Medicus Life Support Catheter and Introducer
K251831 · QHW
Medtronic, Inc.
Cardiovascular · 216d
Cleared Jan 15, 2026
Electric Wheelchair (DH01168)
K251458 · ITI
Foshan Dahao Medical Technology Co.,...
Physical Medicine · 248d
Cleared Jan 15, 2026
Esperance pHLO Aspiration System
K251357 · NRY
Phenox, Ltd.
Neurology · 260d