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
10273–10296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2023
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core...
K230140 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
RAIN Sheath™ Tibial Pedal Introducer
K230704 · DYB
Cordis US Corp
Cardiovascular · 41d
Cleared Apr 21, 2023
Kyphoplasty Balloon System
K221142 · HRX
OK Medinet Korea Co., Ltd.
Orthopedic · 367d
Cleared Apr 21, 2023
CONNEQT PULSE
K221742 · DXN
Atcor Medical
Cardiovascular · 310d
Cleared Apr 21, 2023
AEON Endoscopic Stapler
K222210 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 270d
Cleared Apr 21, 2023
Paradigm System
K222291 · OLO
Proprio, Inc.
Orthopedic · 263d
Cleared Apr 21, 2023
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill...
K222604 · MQC
Dentona AG
Dental · 235d
Cleared Apr 21, 2023
Modular Rotating Hinge Knee Systems and Compatible Components
K223069 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 203d
Cleared Apr 21, 2023
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle,...
K223300 · KNW
Geotek Medikal Ltd Sti
General & Plastic Surgery · 176d
Cleared Apr 21, 2023
ViewFinder Software Version 1.1
K223501 · QIH
Elaitra, Ltd.
Radiology · 151d
Cleared Apr 21, 2023
HERA W10 Diagnostic Ultrasound System
K230084 · IYN
Samsung Medison Co., Ltd.
Radiology · 100d
Cleared Apr 21, 2023
EzDent Web
K230468 · LLZ
Ewoosoft Co., Ltd.
Radiology · 59d
Cleared Apr 21, 2023
Anatase Spine Surgery Navigation System
K230783 · OLO
Remex Medical Corp.
Orthopedic · 30d
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