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
10297–10320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2023
Velacur
K223287 · IYO
Sonic Incytes
Radiology · 177d
Cleared Apr 20, 2023
Neodent Implant System - Helix Short Surgical Kit Cases
K223662 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 135d
Cleared Apr 20, 2023
RadiForce RX270
K223768 · PGY
Eizo Corporation
Radiology · 126d
Cleared Apr 20, 2023
HILINE™ Fixation System
K230565 · OWI
Globus Medical, Inc.
Orthopedic · 50d
Cleared Apr 20, 2023
Precision1, Precision1 for Astigmatism
K230785 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Apr 20, 2023
Deep Learning Image Reconstruction
K230807 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Apr 19, 2023
Selux AST System
K211748 · LON
Selux Diagnostics, Inc.
Microbiology · 681d
Cleared Apr 19, 2023
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse...
K220288 · FPA
Np Medical, Inc.
General Hospital · 442d
Cleared Apr 19, 2023
Renova RP Centesis Pump
K221042 · BTA
Gi Supply, Inc.
General & Plastic Surgery · 376d
Cleared Apr 19, 2023
Montross Extremity Medical Hemi Implant System
K221220 · KWD
Montross Extremity Medical
Orthopedic · 357d
Cleared Apr 19, 2023
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO)...
K223168 · QWF
Medtronic, Inc.
Cardiovascular · 190d
Cleared Apr 19, 2023
TAP Lancet
K223201 · FMK
Yourbio Health, Inc.
General & Plastic Surgery · 187d
Cleared Apr 19, 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements...
K223552 · HAW
Brainlab AG
Neurology · 145d
Cleared Apr 19, 2023
ART-Plan
K230023 · QKB
Therapanacea Sas
Radiology · 105d
Cleared Apr 19, 2023
SimpliFix Hip System
K230053 · HWC
Stabiliz Orthopaedics, Inc.
Orthopedic · 103d
Cleared Apr 19, 2023
Diode Laser Hair Removal
K230090 · OHT
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 97d
Cleared Apr 19, 2023
Altus Spine Monaco Pedicle Screw System
K230766 · NKB
Altus Spine
Orthopedic · 30d
Cleared Apr 18, 2023
SENSOSEEG Depth Electrodes
K213170 · GZL
Sensomedical Labs, Ltd.
Neurology · 567d
Cleared Apr 18, 2023
Terumo Advanced Perfusion System 1
K221895 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 292d
Cleared Apr 18, 2023
UniVy™ OsteoVy™-Ti Cervical IBF System
K223513 · ODP
Vy Spine, LLC
Orthopedic · 147d
Cleared Apr 18, 2023
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
K223784 · GEI
Deltronix Equipamentos Ltda
General & Plastic Surgery · 123d
Cleared Apr 18, 2023
ClotTriever BOLD Catheter
K230494 · QEW
Inari Medical, Inc.
Cardiovascular · 54d
Cleared Apr 18, 2023
Anivia SG1000 Pump Console
K230698 · DWA
Apmtd, Inc.
Cardiovascular · 36d
Cleared Apr 18, 2023
OsteoCentric Integrated Hip Fastener System
K230764 · JDO
OsteoCentric Technologies
Orthopedic · 29d