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
337–360 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 02, 2026
HYALOMATRIX
K261311 · QSZ
Anika Therapeutics, Inc.
General & Plastic Surgery · 134d
Cleared Sep 02, 2026
Ruby Intravascular Catheter
K260432 · FOZ
Venocare, Inc.
General Hospital · 203d
Cleared Sep 02, 2026
Trexo Theo
K254198 · PHL
Trexo Robotics, Inc.
Neurology · 253d
Cleared Sep 02, 2026
I-View®
K254090 · MUE
Hologic, Inc.
Radiology · 257d
Cleared Sep 02, 2026
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U)
K254026 · EOQ
Flexicare Medical Limited.
Ear, Nose, Throat · 260d
Cleared Sep 02, 2026
Momentum Acetabular Cup System
K253948 · LZO
United Orthopedic Corporation
Orthopedic · 266d
Cleared Sep 02, 2026
Aevumed SUPERCYNCH™ Button System
K253065 · MBI
Aevumed, Inc.
Orthopedic · 345d
Cleared Sep 01, 2026
RadiForce MX247W
K262783 · PGY
Eizo Corporation
Radiology · 26d
Cleared Sep 01, 2026
Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
K262774 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 28d
Cleared Sep 01, 2026
Arthrex DynaNite Staples
K262451 · JDR
Arthrex, Inc.
Orthopedic · 46d
Cleared Sep 01, 2026
CO2 Laser System (MBT- CO2 Laser)
K262269 · GEX
Beijing Mega Beauty Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared Sep 01, 2026
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug...
K261811 · QSO
Primed Medical Products, Inc.
General Hospital · 92d
Cleared Sep 01, 2026
UNIDRIVE Select System
K260884 · GCJ
Karl Storz SE & CO. KG
Gastroenterology & Urology · 168d
Cleared Sep 01, 2026
MAGNETOM Free.Max
K260758 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 176d
Cleared Sep 01, 2026
Carescape ONE
K260656 · MHX
GE Healthcare Finland Oy
Cardiovascular · 186d
Cleared Sep 01, 2026
AMI™ Plasma Cartridge, AMI™
K260613 · JID
Sequitur Health Corp.
Chemistry · 188d
Cleared Sep 01, 2026
SK Knee System
K253961 · JWH
Just Medical Devices (Tianjin) Co., Ltd.
Orthopedic · 265d
Cleared Aug 28, 2026
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
K262735 · MXD
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 28, 2026
Primal K-Wire (P99-193-1410)
K262722 · HTY
Paragon 28, Inc.
Orthopedic · 28d
Cleared Aug 28, 2026
Kiba CTO Crossing Catheter
K262013 · PDU
Reflow Medical, Inc.
Cardiovascular · 74d
Cleared Aug 28, 2026
FRAXION 3.5 Plate System (Various - See Catalog)
K261830 · HRS
Ortler Global Tibbi Gerecler Anonim...
Orthopedic · 87d
Cleared Aug 28, 2026
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
K261582 · NUV
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 107d
Cleared Aug 28, 2026
Rayvolve AZchest
K261378 · QBS
AZmed
Radiology · 123d
Cleared Aug 28, 2026
Zoom 4S Catheter
K261176 · QJP
Imperative Care, Inc.
Neurology · 140d