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: 2026–2026 ×
1,642 results
361–384 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 26, 2026
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
K254157 · OLO
Medos International SARL
Orthopedic · 155d
Cleared May 26, 2026
Momcozy Nasal Aspirator (BN007)
K253629 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 188d
Cleared May 26, 2026
VIVA combo RF System
K252833 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 263d
Cleared May 26, 2026
JAZBI™ Resorbable Bone Void Filler
K252797 · MQV
Sdip Innovations Pty, Ltd.
Orthopedic · 265d
Cleared May 26, 2026
Digital ClarusScope System and Digital NeuroPEN System
K252790 · HRX
Clarus Medical, LLC
Orthopedic · 266d
Cleared May 24, 2026
MediBot Needle Driver Uno
K260183 · GCJ
Parallel Robotics, LLC
General & Plastic Surgery · 123d
Cleared May 22, 2026
BioSieve Multi-Drug Urine Test Panel
K261280 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 35d
Cleared May 22, 2026
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens...
K261098 · KOI
Senzime AB
Anesthesiology · 50d
Cleared May 22, 2026
da Vinci Firefly Imaging System
K260695 · NAY
Intuitive Surgical
General & Plastic Surgery · 80d
Cleared May 22, 2026
Apollo TMS Therapy System
K260560 · OBP
Mag & More GmbH
Neurology · 92d
Cleared May 22, 2026
Ion-C Navigation Instruments
K260329 · OLO
SurGenTec, LLC
Orthopedic · 112d
Cleared May 22, 2026
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
K260324 · QIH
Canon Medical Informatics, Inc.
Radiology · 112d
Cleared May 22, 2026
MagVenture Accelerated TMS (aTMS) Therapy System
K260189 · OBP
Tonica Elektronik A/S
Neurology · 120d
Cleared May 22, 2026
uMR Astra
K260113 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared May 22, 2026
InQwire Amplatz Guide Wire
K254137 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 151d
Cleared May 22, 2026
Spectrum-2
K254129 · MUD
Neko Health AB
General & Plastic Surgery · 151d
Cleared May 22, 2026
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort...
K253949 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 163d
Cleared May 22, 2026
Guanhong Sharps Container (GHW-1F1)
K253773 · MMK
Taizhou Huangyan Guanhong Plastic...
General Hospital · 177d
Cleared May 22, 2026
Atmo Gas Capsule System
K253569 · NYV
Atmo Biosciences, Ltd.
Gastroenterology & Urology · 186d
Cleared May 22, 2026
Zenith Distal Access Long Sheath
K253359 · QJP
Suzhou Zenith Vascular SciTech Limited
Neurology · 234d
Cleared May 22, 2026
Sterile Latex Powder Free Surgical Gloves
K253060 · KGO
Protect Gloves Company Limited
General Hospital · 242d
Cleared May 22, 2026
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
K252917 · PZX
Genesee Biomedical, Inc.
Cardiovascular · 252d
Cleared May 22, 2026
AiSteth®
K252915 · DQD
Ai Health Highway India Pvt., Ltd.
Cardiovascular · 252d
Cleared May 22, 2026
DePuy ATTUNE™ Knee System
K252887 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 254d