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
1321–1344 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 15, 2026
Neurophet AQUA
K261273 · QIH
Neurophet., Inc.
Radiology · 28d
Cleared May 15, 2026
Stellaris Elite™ vision enhancement system
K261264 · HQC
Bausch and Lomb
Ophthalmic · 29d
Cleared May 15, 2026
Varion Thoracolumbar Fixation System
K260989 · NKB
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 51d
Cleared May 15, 2026
TruSelect™ 2.6 Microcatheter
K260771 · KRA
Boston Scientific Corporation
Cardiovascular · 67d
Cleared May 15, 2026
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
K260536 · KWL
Depuy Ireland UC
Orthopedic · 87d
Cleared May 15, 2026
Ventana® P/T Lumbar Interbody System
K260506 · MAX
Spinal Elements, Inc.
Orthopedic · 87d
Cleared May 15, 2026
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02
K260134 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 119d
Cleared May 15, 2026
NOVEOS Specific IgE (sIgE)
K260059 · DHB
Hycor Biomedical
Immunology · 127d
Cleared May 15, 2026
SubtleHD-CT (1.x)
K254120 · QIH
Subtle Medical, Inc.
Radiology · 147d
Cleared May 15, 2026
Manual Tissue Removal Device
K254050 · HIH
Suzhou AcuVu Medical Technology Co.,...
Obstetrics & Gynecology · 149d
Cleared May 15, 2026
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior,...
K254028 · IYN
Sonoscape Medical Corp.
Radiology · 150d
Cleared May 15, 2026
medXion NEXUS
K253935 · OAS
medXion Technologies, Inc.
Radiology · 157d
Cleared May 15, 2026
cobas liat CT/NG/MG nucleic acid test
K253759 · QEP
Roche Molecular Systems, Inc.
Microbiology · 171d
Cleared May 15, 2026
cobas liat CT/NG nucleic acid test
K253756 · QEP
Roche Molecular Systems, Inc.
Microbiology · 171d
Cleared May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE...
K253716 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 172d
Cleared May 15, 2026
Jada System (Jada-2002)
K253642 · OQY
Organon, LLC
Obstetrics & Gynecology · 177d
Cleared May 15, 2026
Introcan Safety® Deep Access XL IV Catheter
K253235 · FOZ
B.Braun Medical, Inc.
General Hospital · 228d
Cleared May 15, 2026
Iso-Gard Filter Straight
K252643 · CAH
Teleflex Medical Sdn. Bhd.
General Hospital · 267d
Cleared May 15, 2026
KARL STORZ Laryngoscopes and Accessories
K252624 · EQN
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 270d
Cleared May 15, 2026
Neurophet SCALE PET
K252563 · QIH
Neurophet., Inc.
Radiology · 274d
Cleared May 15, 2026
NovaLine Tubing Set for Hemodialysis (BL 124)
K252423 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 287d
Cleared May 15, 2026
NxStage System One with NxView
K252377 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 289d
Cleared May 14, 2026
BriefCase-Triage
K261317 · QAS
Aidoc Medical , Ltd.
Radiology · 23d
Cleared May 14, 2026
TriMed Compression Screws
K261241 · HWC
TriMed, Inc.
Orthopedic · 29d