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
10561–10584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2023
Knee+
K230789 · SBF
Pixee Medical
Orthopedic · 30d
Cleared Apr 21, 2023
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
K230808 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 29d
Cleared Apr 21, 2023
Digital Intraoral X-Ray Sensor
K230811 · MUH
Iray Imaging Technology (Haining)...
Radiology · 28d
Cleared Apr 21, 2023
Intense Pulsed Light Treatment System
K230816 · ONF
Shangdong Huamei Technology Co., Ltd.
General & Plastic Surgery · 28d
Cleared Apr 21, 2023
OmniGuide RFID Surgical Laser Fibers
K230819 · GEX
Omni-Guide Holdings, Inc.
General & Plastic Surgery · 28d
Cleared Apr 20, 2023
Inomax DSIR
K211153 · MRN
Mallinckrodt Manufacturing, LLC
Anesthesiology · 731d
Cleared Apr 20, 2023
ArtFX Spinal Fixation System
K212220 · NKB
Artfx Medical, LLC
Orthopedic · 643d
Cleared Apr 20, 2023
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · DWP
Fehling Surgical Instruments, Inc.
Cardiovascular · 381d
Cleared Apr 20, 2023
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter,...
K222095 · QEY
Thrombolex, Inc.
Cardiovascular · 276d
Cleared Apr 20, 2023
Flexible Video-Choledochoscope System
K222261 · FBN
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 266d
Cleared Apr 20, 2023
STARband 3D
K223238 · MVA
Orthomerica Products, Inc.
Neurology · 182d
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