FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12049–12072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2022
CW60N
K222722 · PGY
Wide Corporation
Radiology · 53d
Cleared Oct 30, 2022
Nuheara IQbuds 2 PRO Hearing Aid
K221064 · QUH
Nuheara Limited
Ear, Nose, Throat · 202d
Cleared Oct 28, 2022
Disposable Surgical Gown Rk-3011C
K211060 · FYA
Xiantao Rhycom Non-Woven Products...
General Hospital · 567d
Cleared Oct 28, 2022
Welch Allyn Connex Central Station
K212473 · MWI
Welch Allyn, Inc.
Cardiovascular · 448d
Cleared Oct 28, 2022
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
K214109 · GXN
Kontour(Xi?An) Medical Technology...
Neurology · 303d
Cleared Oct 28, 2022
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
K220305 · PZX
Syntheon
Cardiovascular · 268d
Cleared Oct 28, 2022
Vapotherm Aerosol Adapter AAA-2
K220869 · CAF
Vapotherm, Inc.
Anesthesiology · 217d
Cleared Oct 28, 2022
Vented Vial Transfer Pin
K221406 · LHI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 165d
Cleared Oct 28, 2022
SUPERTILT PLUS (STP)
K221435 · IOR
Power Plus Mobility
Physical Medicine · 164d
Cleared Oct 28, 2022
Disposable Safety Lancet
K221521 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 156d
Cleared Oct 28, 2022
Non Sterile Powder Free Latex Examination Glove
K221667 · LYY
New Era Medicare Sdn. Bhd.
General Hospital · 142d
Cleared Oct 28, 2022
Spinal Inner Fixation System
K222031 · NKB
Changzhou Geasure Medical Apparatus...
Orthopedic · 109d
Cleared Oct 28, 2022
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20,...
K222191 · IYN
Supersonic Imagine
Radiology · 98d
Cleared Oct 28, 2022
Stela Automix System
K222581 · EBF
Sdi Limited
Dental · 63d
Cleared Oct 28, 2022
Stela Capsule System
K222583 · EBF
Sdi Limited
Dental · 63d
Cleared Oct 28, 2022
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
K222653 · NJD
Smith & Nephew, Inc.
Orthopedic · 57d
Cleared Oct 28, 2022
VS3-Iridium System (VS3-IR)
K223020 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 29d
Cleared Oct 28, 2022
ALLY II Uterine Positioning System™ (UPS)
K223064 · LKF
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared Oct 28, 2022
Remi Robotic Navigation System
K223070 · OLO
Fusion Robotics, LLC
Orthopedic · 28d
Cleared Oct 28, 2022
Stage
K223079 · LNH
Spintech, Inc.
Radiology · 28d
Cleared Oct 28, 2022
Bakri Essential Postpartum Balloon
K223098 · OQY
Cook Incorporated
Obstetrics & Gynecology · 28d
Cleared Oct 27, 2022
ORAcollect®•Dx
K212745 · OYJ
DNA Genotek, Inc.
Chemistry · 423d
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332 · LNH
Shanghai United Imaging Healthcare...
Radiology · 265d
Cleared Oct 27, 2022
Arthrex BioSuture
K220880 · GAT
Arthrex, Inc.
General & Plastic Surgery · 216d