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
4465–4488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2025
Green X 21 (PHT-90CHO)
K243081 · OAS
VATECH Co., Ltd.
Radiology · 137d
Cleared Feb 14, 2025
LimFlow V-Ceiver
K242776 · MMX
LimFlow, Inc.
Cardiovascular · 154d
Cleared Feb 14, 2025
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F,...
K242593 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 168d
Cleared Feb 14, 2025
ICS Dizcovery (1091)
K242198 · GWN
Natus Medical Denmark Aps
Ear, Nose, Throat · 203d
Cleared Feb 14, 2025
WARD-CSS (v1.2.x)
K241958 · MWI
Ward 24/7 Aps
Cardiovascular · 226d
Cleared Feb 14, 2025
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
K241643 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 252d
Cleared Feb 14, 2025
Alinity m Resp-4-Plex
K241573 · QOF
Abbott Molecular, Inc.
Microbiology · 256d
Cleared Feb 14, 2025
Pastelle Pro
K241527 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 260d
Cleared Feb 13, 2025
FaStep Pregnancy Rapid Test Cassette
K250117 · LCX
Assure Tech., LLC
Chemistry · 28d
Cleared Feb 13, 2025
Newclip Patient-matched instrumentation non sterile PSI
K243912 · PBF
Newclip Technics
Orthopedic · 56d
Cleared Feb 13, 2025
Body Temperature Software (BTS)
K243778 · QZA
Fitbit, LLC
General Hospital · 66d
Cleared Feb 13, 2025
AH Plus Endodontic Sealer
K243546 · KIF
Dentsply Sirona, Inc.
Dental · 90d
Cleared Feb 13, 2025
Aptima SARS-CoV-2 Assay
K243396 · QQX
Hologic, Inc.
Microbiology · 105d
Cleared Feb 13, 2025
Ampa One System (AMPA-001)
K243319 · OBP
Neuromodulatory Devices & Applications
Neurology · 113d
Cleared Feb 13, 2025
Integrated Endo System (Meet Endo-II)
K242317 · ELC
Denjoy Dental Co., Ltd.
Dental · 192d
Cleared Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
K242104 · NRY
Penumbra, Inc.
Neurology · 210d
Cleared Feb 13, 2025
Unicorn+ RF System (Unicorn+)
K241832 · GEI
Boston Aesthetics, Inc.
General & Plastic Surgery · 233d
Cleared Feb 13, 2025
Freedom® Total Knee System - Porous Tibial Base Plate
K241597 · MBH
Maxx Orthopedics, Inc.
Orthopedic · 255d
Cleared Feb 13, 2025
EDEN ControlCath
K241410 · BSO
Jmt Co., Ltd.
Anesthesiology · 272d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243962 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243961 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
Affixus Tibial Nailing System - 4mm screws
K243907 · HSB
Zimmer, Inc.
Orthopedic · 55d
Cleared Feb 12, 2025
V8 Diagnostic Ultrasound System
K243702 · IYN
Samsung Medison Co., Ltd.
Radiology · 75d
Cleared Feb 12, 2025
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG...
K243575 · MYF
Biokit, S.A.
Microbiology · 85d