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

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175,820 results
15217–15240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 06, 2022
Penta Glove
K212847 · LZA
Pentavest Holdings Sdn Bhd
General Hospital · 121d
Cleared Jan 06, 2022
Gold Anchor
K213053 · IYE
Naslund Medical AB
Radiology · 106d
Cleared Jan 06, 2022
TOMTEC-ARENA
K213544 · QIH
Tomtec Imaging Systems GmbH
Radiology · 59d
Cleared Jan 06, 2022
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K213546 · OLO
Blue Ortho
Orthopedic · 59d
Cleared Jan 06, 2022
DePuy Corail AMT Hip Prosthesis
K213839 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Jan 06, 2022
ENEO TOTALE (Model: ENEOT947)
K213841 · OHS
Premier North America, Inc.
General & Plastic Surgery · 28d
Cleared Jan 05, 2022
Urethral Warming Catheter Kit
K211149 · GEH
Varian Medical Systems, Inc.
General & Plastic Surgery · 261d
Cleared Jan 05, 2022
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use...
K211318 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 250d