FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
4129–4152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2025
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
K250194 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 62d
Cleared Mar 26, 2025
Power Wheelchair (YH-E6011,YH-E6013A)
K250134 · ITI
Ningbo Youhuan Automation Technology...
Physical Medicine · 68d
Cleared Mar 26, 2025
Electrically powered wheelchair
K244003 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 90d
Cleared Mar 26, 2025
Arthrex Humeral Plating System and Cerclage Button
K243995 · HRS
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 26, 2025
EarliPoint System
K243891 · QPF
Earlitec Diagnostics
Neurology · 98d
Cleared Mar 26, 2025
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
K243840 · KDN
Bridge TO Life
Gastroenterology & Urology · 103d
Cleared Mar 26, 2025
Rayvolve LN
K243831 · MYN
AZmed
Radiology · 103d
Cleared Mar 26, 2025
SnapshotGLO (KB100)
K242669 · QJF
Kent Imaging, Inc.
General & Plastic Surgery · 202d
Cleared Mar 26, 2025
SB Knife Jr2 (MD-47702 and MD-47702L)
K241855 · KNS
Sb-Kawasumi Laboratories, Inc.
Gastroenterology & Urology · 272d
Cleared Mar 26, 2025
NM-01/CPT neurometer (NM-01/CPT)
K240189 · JXE
Mde Orvosbiol?giai Kutat?, Fejleszto,
Neurology · 427d
Cleared Mar 25, 2025
Aventus Thrombectomy System (IM-2100)
K250668 · QEW
Inquis Medical
Cardiovascular · 20d
Cleared Mar 25, 2025
Bolt Intravascular Lithotripsy (IVL) System
K250225 · PPN
Bolt Medical, Inc.
Cardiovascular · 57d
Cleared Mar 24, 2025
AxTiHA® Stand-Alone ALIF System
K250603 · OVD
Innovasis
Orthopedic · 24d
Cleared Mar 24, 2025
Innovasis Navigation Instruments
K250182 · OLO
Innovasis, Inc.
Orthopedic · 61d
Cleared Mar 24, 2025
LMNT O2
K250125 · OHS
Xplr , Ltd.
General & Plastic Surgery · 66d
Cleared Mar 24, 2025
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S,...
K250013 · QEZ
Control Medical Technology, Inc. /...
Cardiovascular · 81d
Cleared Mar 24, 2025
Klassic Knee System - Revision Tibial Baseplate
K243991 · JWH
Total Joint Othopedics, Inc.
Orthopedic · 88d
Cleared Mar 24, 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · LFL
Stryker Instruments
General & Plastic Surgery · 94d
Cleared Mar 24, 2025
AERO MIS Facet Fusion System
K243865 · MRW
Aurora Spine
Orthopedic · 97d
Cleared Mar 24, 2025
UltraCor™ Twirl™ Breast Tissue Marker
K243642 · NEU
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 118d
Cleared Mar 24, 2025
SonoTAP and SonoTAP II
K243525 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 130d
Cleared Mar 24, 2025
Glean Urodynamics System Male Delivery System (GUS-1000-M)
K243052 · EXQ
Bright Uro, Inc.
Gastroenterology & Urology · 178d
Cleared Mar 24, 2025
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
K242893 · OBJ
Luma Vision Limited
Cardiovascular · 182d
Cleared Mar 24, 2025
TIDAL Fusion Cage System
K242356 · SAI
Restor3D, Inc.
Orthopedic · 228d