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
10993–11016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2023
DeltaScan Monitor
K222680 · NCG
Prolira B.V.
Neurology · 149d
Cleared Feb 02, 2023
Oncospace
K222803 · MUJ
Oncospace, Inc.
Radiology · 139d
Cleared Feb 02, 2023
SutureLoc™ Implant
K223284 · MBI
Arthrex, Inc.
Orthopedic · 100d
Cleared Feb 02, 2023
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
K223362 · OVE
4Web Medical, Inc.
Orthopedic · 91d
Cleared Feb 02, 2023
SmartRelease Endoscopic Soft Tissue Release System
K223406 · HRX
Microaire Surgical Instruments
General Hospital · 85d
Cleared Feb 02, 2023
PreView-III™ Anterior Cervical Plate System
K223627 · KWQ
Nexus Spine, LLC
Orthopedic · 59d
Cleared Feb 02, 2023
Atomica Planner
K230012 · LLZ
Atomica Technology, Inc.
Radiology · 30d
Cleared Feb 01, 2023
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
K213480 · MOS
Rapid Biomedical GmbH
Radiology · 460d
Cleared Feb 01, 2023
Tinnitogram Signal Generator
K221168 · KLW
Goldenear Company, Inc.
Ear, Nose, Throat · 285d
Cleared Feb 01, 2023
EmbedMed
K221943 · PBF
3D Lifeprints UK , Ltd.
Orthopedic · 211d
Cleared Feb 01, 2023
LED Light Therapy Device, KN-7000L
K222751 · GEX
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 142d
Cleared Feb 01, 2023
Garment Electrodes
K222863 · GXY
Tone-A-Matic International, Inc.
Neurology · 132d
Cleared Feb 01, 2023
LVivo IQS
K222970 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 127d
Cleared Feb 01, 2023
Certas Plus Programmable Valves
K223330 · JXG
Integra Lifesciences Production...
Neurology · 93d
Cleared Feb 01, 2023
Rapid RV/LV
K223396 · QIH
Ischemaview, Inc.
Radiology · 85d
Cleared Feb 01, 2023
BriefCase
K230020 · QFM
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Jan 31, 2023
XBody Go USA, XBody Pro USA
K221200 · NGX
Xbody Hungary Kft.
Physical Medicine · 280d
Cleared Jan 31, 2023
V-SPERM WASH
K223117 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 120d
Cleared Jan 31, 2023
Naviswiss Knee
K223351 · OLO
Naviswiss AG
Orthopedic · 90d
Cleared Jan 30, 2023
XChange Device, XChange System
K210112 · CCK
Pneuma Therapeutics, Inc.
Anesthesiology · 741d
Cleared Jan 30, 2023
PHMB Wound Dressing
K221532 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 30, 2023
Playground For All Love Sesh
K222567 · NUC
Playground For All
Obstetrics & Gynecology · 159d
Cleared Jan 30, 2023
My3D® Personalized Pelvic Reconstruction
K223348 · LPH
Onkos Surgical, Inc.
Orthopedic · 89d
Cleared Jan 28, 2023
BrainView QEEG Software
K212684 · OLU
Medeia, Inc.
Neurology · 522d