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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14113–14136 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2022
GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6...
K210198 · HRS
Gpc Medical Limited
Orthopedic · 347d
Cleared Jan 07, 2022
Infrared Thermometer
K210564 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared Jan 07, 2022
Agile Devices Angler Steerable, Deflectable Microcatheter
K211110 · KRA
Agile Devices, Inc.
Cardiovascular · 268d
Cleared Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · ONO
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Jan 07, 2022
Selebrek PTCA Balloon Dilatation Catheter
K211349 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 249d
Cleared Jan 07, 2022
AIBOLIT 3D+
K211443 · LLZ
Aibolit Technologies, LLC
Radiology · 242d
Cleared Jan 07, 2022
DropSafe Safety Pen Needles
K211716 · FMI
Htl Strefa SA
General Hospital · 218d
Cleared Jan 07, 2022
SignaSure Dual Mobility System
K211742 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 214d
Cleared Jan 07, 2022
Fetal Doppler
K211940 · KNG
Shenzhen Taikang Medical Equipment...
Obstetrics & Gynecology · 198d
Cleared Jan 07, 2022
Picocaremajesty
K212127 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 184d
Cleared Jan 07, 2022
Prelude IDeal 9F Hydrophilic Sheath Introducer
K212152 · DYB
Merit Medical Systems
Cardiovascular · 182d
Cleared Jan 07, 2022
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K212166 · GWF
Inomed Medizintechnik GmbH
Neurology · 179d
Cleared Jan 07, 2022
Pectus Blu Support Bar System
K212841 · HRS
Biomet Micofixation
Orthopedic · 122d
Cleared Jan 07, 2022
Tesera-k ALIF System
K212980 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 112d
Cleared Jan 07, 2022
Acumed Ankle Syndesmosis Repair System
K212990 · HTN
Acumed, LLC
Orthopedic · 109d
Cleared Jan 07, 2022
CELERITY HP Chemical Indicator
K213262 · QKM
STERIS Corporation
General Hospital · 99d
Cleared Jan 07, 2022
Dental Zirconia Ceramic
K213570 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 58d
Cleared Jan 07, 2022
Vital Navigation System
K213720 · OLO
Zimvie (Zimmer Biomet Spine, Inc.)
Orthopedic · 44d
Cleared Jan 07, 2022
Custom Stable Rigid Gas Permeable Scleral Contact Lens
K213880 · HQD
Valley Contax, Inc.
Ophthalmic · 25d
Cleared Jan 07, 2022
Cyclops™ Anterior Cervical Plate System
K213901 · KWQ
Degen Medical
Orthopedic · 24d
Cleared Jan 06, 2022
Enlight 2100
K211135 · QEB
Timpel S.A.
Anesthesiology · 265d
Cleared Jan 06, 2022
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
K211499 · QAZ
23AndMe, Inc.
Medical Genetics · 237d
Cleared Jan 06, 2022
Tigereye CTO-Crossing Catheter
K212468 · PDU
Avinger, Inc.
Cardiovascular · 153d
Cleared Jan 06, 2022
iPrime Viscodelivery System
K212797 · MRH
Glaukos
Ophthalmic · 126d