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
12313–12336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2022
Ez3D-i/E3
K222069 · LLZ
Ewoosoft Co., Ltd.
Radiology · 54d
Cleared Sep 02, 2022
Camber Sacroiliac (SI) Fixation System
K203503 · OUR
Camber Spine Technologies, LLC
Orthopedic · 641d
Cleared Sep 02, 2022
DURAMESH Mesh Suture
K211178 · GAW
Msi
General & Plastic Surgery · 500d
Cleared Sep 02, 2022
FibroLux
K212189 · NHN
Multi Radiance Medical
Physical Medicine · 416d
Cleared Sep 02, 2022
Soniquence Reusable 3 Button Fingerswitch Wand
K212222 · GEI
Soniquence, LLC
General & Plastic Surgery · 413d
Cleared Sep 02, 2022
StageOne Knee Cement Spacer Molds
K213287 · MBB
Biomet, Inc.
Orthopedic · 336d
Cleared Sep 02, 2022
Arrow Pressure Injectable Midline Catheter
K213855 · PND
Arrow International, LLC Subsidiary...
General Hospital · 266d
Cleared Sep 02, 2022
Bonebridge Osteosynthesis Plating System
K213864 · HRS
Bonebridge AG
Orthopedic · 266d
Cleared Sep 02, 2022
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for...
K213983 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 256d
Cleared Sep 02, 2022
LiNA OperaScope Needle
K221085 · FBK
Lina Medical Aps
Obstetrics & Gynecology · 142d
Cleared Sep 02, 2022
Mygen M-3004 RF Generator M-3004
K221277 · GEI
RF Medical Co., Ltd.
General & Plastic Surgery · 122d
Cleared Sep 02, 2022
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
K221414 · LIT
Silk Road Medical, Inc.
Cardiovascular · 109d
Cleared Sep 02, 2022
Visera Hysterovideoscope Olympus HYF Type V
K221557 · HIH
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 94d
Cleared Sep 02, 2022
Synthetic Bone Putty
K221644 · MQV
Ventris Medical
Orthopedic · 88d
Cleared Sep 02, 2022
Omni Legend
K221932 · KPS
Ge Healthcare
Radiology · 63d
Cleared Sep 02, 2022
Savewo ClassicMASK
K221957 · FXX
Savewo Limited
General Hospital · 59d
Cleared Sep 02, 2022
CellFX System
K222075 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 50d
Cleared Sep 02, 2022
Perfetta Moderate Medical Face Mask
K222426 · FXX
Phu Bao Group Company Limited
General Hospital · 22d
Cleared Sep 01, 2022
Soteria Bed Barrier
K201876 · QTV
Trinity Guardion
General & Plastic Surgery · 786d
Cleared Sep 01, 2022
Knee+
K220104 · SBF
Pixee Medical
Orthopedic · 232d
Cleared Sep 01, 2022
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
K220177 · OBP
Magnus Medical, Inc.
Neurology · 223d
Cleared Sep 01, 2022
FOX 810, FOX 980
K220531 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 189d
Cleared Sep 01, 2022
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION...
K220563 · GEI
ArthroCare Corporation
General & Plastic Surgery · 185d
Cleared Sep 01, 2022
Hybrid C70
K220579 · EHD
Digimed Co., Ltd.
Radiology · 192d