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: Cleared only ×
175,820 results
18193–18216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2021
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
K201836 · JAK
Canon Medical Systems Corporation
Radiology · 194d
Cleared Jan 12, 2021
Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
K202843 · FXX
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General Hospital · 109d
Cleared Jan 12, 2021
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
K203129 · OVE
Precision Spine, Inc.
Orthopedic · 85d
Cleared Jan 12, 2021
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System,...
K203201 · MAX
Nu Vasive, Incorporated
Orthopedic · 75d
Cleared Jan 12, 2021
Hepatica v1 (Hepatica v1.0.0)
K203280 · LNH
Perspectum, Ltd.
Radiology · 67d
Cleared Jan 12, 2021
C Scope Visualization System
K203526 · HRX
Cit Ortho
Orthopedic · 41d
Cleared Jan 12, 2021
Micro C Medical Imaging System, M01
K203658 · IZL
Oxos Medical, Inc.
Radiology · 28d
Cleared Jan 11, 2021
ICE COMPRESSION FIRST, DUO, & MOOVE Systems
K193079 · IRP
Mks Paris
Physical Medicine · 433d
Cleared Jan 11, 2021
Striate+™
K201241 · NPL
Orthocell, Ltd.
Dental · 248d
Cleared Jan 11, 2021
M-Vizion Femoral Revision System Extension
K201471 · LZO
Medacta International S.A.
Orthopedic · 222d
Cleared Jan 11, 2021
GetSet Surgical GoPLF! Posterior Lateral Fusion System
K202505 · NKB
Getset Surgical, SA
Orthopedic · 133d
Cleared Jan 11, 2021
Medical Surgical Mask-Model MP002-5, MP002-6
K202577 · FXX
Jiangmen Sure&Me Medical Product Co.,...
General Hospital · 125d
Cleared Jan 11, 2021
Switched Internal Paddles
K203231 · LDD
Philips North America, LLC
Cardiovascular · 70d
Cleared Jan 11, 2021
Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)-...
K203397 · KNW
Biopsybell S.R.L.
General & Plastic Surgery · 54d
Cleared Jan 09, 2021
CLEWICU System (ClewICUServer and ClewICUnitor)
K200717 · QNL
Clew Medical , Ltd.
Cardiovascular · 297d
Cleared Jan 09, 2021
Puritan Bennett Cuff Pressure Manager
K202874 · BSK
Covidien, LLC
Anesthesiology · 103d
Cleared Jan 08, 2021
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
K201259 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 242d
Cleared Jan 08, 2021
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778 · QAT
Abbott Laboratories
Immunology · 192d
Cleared Jan 08, 2021
Passion Natural Water Based Lubricant
K202017 · NUC
Xr, LLC
Obstetrics & Gynecology · 171d
Cleared Jan 08, 2021
OBS Anchorage Screw, Biokey Anchorage Screw
K202278 · OAT
Bomei Co, Ltd.
Dental · 150d
Cleared Jan 08, 2021
Button Loop
K202291 · MBI
Yunyi (Beijing) Medical Device Co., Ltd.
Orthopedic · 149d
Cleared Jan 08, 2021
Celerity 20 Steam Biological Indicator for IUSS
K202721 · FRC
STERIS Corporation
General Hospital · 113d
Cleared Jan 08, 2021
LOGIQ P10, LOGIQ P9, LOGIQ P8
K203114 · IYN
GE Medical Systems Ultrasound and...
Radiology · 85d
Cleared Jan 08, 2021
HeartFlow Analysis
K203329 · PJA
HeartFlow, Inc.
Cardiovascular · 57d