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: Cleared only ×
174,955 results
1489–1512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2026
NeuroSpan Bridge
K253363 · JXI
Auxilium Biotechnologies, Inc.
Neurology · 109d
Cleared Jan 17, 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
K251970 · LOX
Medtronic, Ireland
Cardiovascular · 205d
Cleared Jan 16, 2026
Azurion R3.1
K254186 · OWB
Philips Medical Systems B.V.
Radiology · 24d
Cleared Jan 16, 2026
Natrelle 133S Tissue Expanders
K254126 · LCJ
AbbVie
General & Plastic Surgery · 28d
Cleared Jan 16, 2026
da Vinci SP Surgical System (SP1098)
K253556 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 63d
Cleared Jan 16, 2026
CoolTone
K253408 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 108d
Cleared Jan 16, 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · DJG
Lin-Zhi International, Inc.
Toxicology · 115d
Cleared Jan 16, 2026
SOLIUS PRO UVB Light Panel
K252960 · SGZ
Solius Labs, Inc.
General & Plastic Surgery · 122d
Cleared Jan 16, 2026
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
K252775 · DHB
Hycor Biomedical
Immunology · 136d
Cleared Jan 16, 2026
actiTENS mini
K252767 · GZJ
Sublimed
Neurology · 140d
Cleared Jan 16, 2026
Imagine® Enterprise Suite
K252634 · QIH
Softlink International Private Limited
Radiology · 149d
Cleared Jan 16, 2026
Toro 88 Superbore Catheter
K252297 · QJP
Toro Neurovascular, Inc.
Neurology · 177d
Cleared Jan 16, 2026
Curiteva Porous PEEK Cervical Interbody System
K252205 · ODP
Curiteva, Inc.
Orthopedic · 186d
Cleared Jan 16, 2026
qXR-Detect
K251934 · MYN
Qure.Ai Technologies
Radiology · 206d
Cleared Jan 16, 2026
MY01 Continuous Compartmental Pressure Monitor
K251900 · LXC
MY01, Inc.
Orthopedic · 210d
Cleared Jan 16, 2026
SeptAlign
K251790 · NHB
Spirair, Inc.
Ear, Nose, Throat · 219d
Cleared Jan 16, 2026
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
K251744 · DTM
Medtronic
Cardiovascular · 224d
Cleared Jan 16, 2026
da Vinci Surgical System (IS5000)
K251739 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 224d
Cleared Jan 16, 2026
Xpert GI Panel
K251721 · PCH
Cepheid
Microbiology · 226d
Cleared Jan 16, 2026
Ion-C
K251714 · MRW
SurGenTec, LLC
Orthopedic · 227d
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