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
1681–1704 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Feb 02, 2026
BIORES Dental Implant System
K252286 · DZE
Chengdu Besmile Medical Technology...
Dental · 194d
Cleared Feb 02, 2026
CHIKAI Nexus petit
K252011 · MOF
Asahi Intecc Co., Ltd.
Neurology · 220d
Cleared Feb 02, 2026
Redermax Antibacterial Wound Matrix
K251582 · FRO
Beijing Kreate Medical Co., Ltd.
General & Plastic Surgery · 255d
Cleared Feb 02, 2026
Vital Signs
K251200 · QME
Oxehealth Limited
Cardiovascular · 290d
Cleared Jan 31, 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 60d
Cleared Jan 30, 2026
BAROguard Donor Lung Preservation System
K254305 · KDN
Paragonix Technologies, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 30, 2026
ZenTite (Unicorn+)
K254290 · GEI
Shenzhen Peninsula Medical Group
General & Plastic Surgery · 30d
Cleared Jan 30, 2026
BruxZir® Shaded 16 PLUS
K254283 · EIH
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared Jan 30, 2026
Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003,...
K253833 · OHS
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 60d
Cleared Jan 30, 2026
Dual Stage Venous Cannulae
K253671 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 70d
Cleared Jan 30, 2026
Clungene RSV Antigen Rapid Test
K253318 · GQG
Hangzhou Clongene Biotech Co., Ltd.
Microbiology · 122d
Cleared Jan 30, 2026
Disposable Distal End Tape Hood
K252457 · FDF
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 178d
Cleared Jan 30, 2026
Boston PICO (Boston PICO)
K251981 · GEX
Boston Aesthetics, Inc.
General & Plastic Surgery · 217d
Cleared Jan 30, 2026
RevealAI-Lung
K251769 · POK
Precision Medical Ventures, Inc. Dba...
Radiology · 234d
Cleared Jan 30, 2026
Motor Handpiece and Control Unit (SDI10)
K251407 · EBW
Saeshin Precision Co., Ltd.
Dental · 269d
Cleared Jan 30, 2026
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113,...
K250983 · SCL
Asistan Medikal
General Hospital · 305d
Cleared Jan 29, 2026
Y-Knotless™ Flex Anchors
K253763 · MBI
Conmed Corporation
Orthopedic · 65d
Cleared Jan 29, 2026
Manual Wheelchair (W50)
K253632 · IOR
Jiangsu Jumao X-Care Medical...
Physical Medicine · 71d
Cleared Jan 29, 2026
Falco Fusion System
K253611 · OUR
Mcnicoll Surgical, Inc.
Orthopedic · 72d
Cleared Jan 29, 2026
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
K253462 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 114d
Cleared Jan 29, 2026
Labcorp Fentanyl Urine Visual Test
K252684 · DJG
Medtox Diagnostics, Inc.
Toxicology · 157d
Cleared Jan 29, 2026
Neurophet AQUA AD Plus
K252496 · QIH
Neurophet., Inc.
Radiology · 174d
Cleared Jan 29, 2026
Electric Scooter (Mojo-T330)
K252349 · INI
Dongguan Smarfody Mobility Technology...
Physical Medicine · 184d
Cleared Jan 29, 2026
Electric Scooter (Mojo-T580)
K252347 · INI
Dongguan Smarfody Mobility Technology...
Physical Medicine · 184d