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
265–288 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 10, 2026
BioTeke® Multi-Drug Urine Test Cup
K261409 · NFT
Bioteke Corporation (Wuxi) Co., Ltd.
Toxicology · 133d
Cleared Sep 10, 2026
4DM
K260879 · QIH
INVIA, LLC
Radiology · 177d
Cleared Sep 10, 2026
danumed Extension Set for Gastrostomy Button
K260110 · PIF
Danumed Medizintechnik GmbH
Gastroenterology & Urology · 239d
Cleared Sep 10, 2026
LT Antibacterial Foam with Silver Dressing
K254246 · NAD
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 255d
Cleared Sep 10, 2026
Irrigation/Urology Sets
K254111 · LJH
B.Braun Medical, Inc.
Gastroenterology & Urology · 265d
Cleared Sep 10, 2026
TruPress
K254074 · DRS
Procerus Enterprises
Cardiovascular · 266d
Cleared Sep 10, 2026
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
K254009 · SJH
Lakong Medical Devices Co., Ltd.
Dental · 269d
Cleared Sep 10, 2026
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K253856 · HAW
KOH YOUNG TECHNOLOGY, Inc.
Neurology · 281d
Cleared Sep 09, 2026
Biodegradable Nitrile Powder Free Examination Glove, Green
K262542 · LZA
Top Glove Sdn. Bhd.
General Hospital · 48d
Cleared Sep 09, 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3,...
K262488 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 51d
Cleared Sep 09, 2026
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs...
K261793 · LZA
Maxter Healthcare, Inc.
General Hospital · 103d
Cleared Sep 09, 2026
QF10
K261470 · NHV
E.A.M Benelux B.V
Gastroenterology & Urology · 128d
Cleared Sep 09, 2026
SIS BLU (SISBLU-30-01)
K260997 · PLL
Endoclot Plus Co., Ltd.
Gastroenterology & Urology · 167d
Cleared Sep 09, 2026
ColActive Plus
K260652 · KGN
Covalon Technologies, Ltd.
General & Plastic Surgery · 194d
Cleared Sep 09, 2026
ChestView US (1.1)
K252486 · MYN
Gleamer
Radiology · 398d
Cleared Sep 09, 2026
ReVISION 2
K251417 · QIH
Argus Cognitive, Inc.
Radiology · 490d
Cleared Sep 08, 2026
b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem...
K262341 · JWH
B-One Ortho, Corp.
Orthopedic · 60d
Cleared Sep 08, 2026
N22 Offset Humeral Head
K262173 · KWT
Shoulder Innovations, Inc.
Orthopedic · 74d
Cleared Sep 08, 2026
Reusable SmartPeg
K261987 · EKX
Osstell AB
Dental · 88d
Cleared Sep 08, 2026
Dental Barriers and Sleeves (AB0006)
K261956 · PEM
ANI Co., Ltd.
Dental · 89d
Cleared Sep 08, 2026
da Vinci Surgical System, Model IS5000
K261823 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 99d
Cleared Sep 08, 2026
Emboliner Embolic Protection System (EPC-03)
K261715 · PUM
Emboline, Inc.
Cardiovascular · 109d
Cleared Sep 08, 2026
LANDMARK Total Knee System
K261462 · MBH
Smith & Nephew, Inc.
Orthopedic · 127d
Cleared Sep 08, 2026
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32...
K260312 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 221d