FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16657–16680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2021
Dental Impression Material
K211489 · ELW
Nanchang Dental Bright Technology...
Dental · 76d
Cleared Jul 28, 2021
Surgical Mask
K211497 · FXX
Honeywell Safety Products
General Hospital · 75d
Cleared Jul 28, 2021
FINE Osteotomy
K211646 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 61d
Cleared Jul 28, 2021
ELEOS Limb Salvage System
K211677 · KRO
Onkos Surgical
Orthopedic · 57d
Cleared Jul 28, 2021
Electrode Market Disposable Surface Electrodes
K211839 · GXY
Electrode Market Co., Ltd.
Neurology · 44d
Cleared Jul 28, 2021
TAIJI Professional Series Level 3 Surgical Face Mask
K211861 · FXX
Taiji Medical Supplies, Inc.
General Hospital · 42d
Cleared Jul 28, 2021
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip...
K211874 · DTK
William Cook Europe Aps
Cardiovascular · 41d
Cleared Jul 28, 2021
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook...
K211875 · DTK
William Cook Europe Aps
Cardiovascular · 41d
Cleared Jul 28, 2021
Catalyst R1 Reverse Shoulder System
K211991 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 30d
Cleared Jul 28, 2021
Braun Silk.expert Mini
K211994 · OHT
Cyden Limited
General & Plastic Surgery · 30d
Cleared Jul 27, 2021
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair,...
K201326 · DJG
Psychemedics Corporation
Toxicology · 434d
Cleared Jul 27, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot...
K210016 · HRS
Integra LifeSciences Corporation
Orthopedic · 204d
Cleared Jul 27, 2021
Insight Agile DRF
K210469 · JAA
Imaging Engineering, LLC
Radiology · 161d
Cleared Jul 27, 2021
Route 92 Medical Full Length 088 Access System
K210635 · QJP
Route 92 Medical, Inc.
Neurology · 146d
Cleared Jul 27, 2021
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
K210664 · PDU
Ra Medical Systems,Inc
Cardiovascular · 144d
Cleared Jul 27, 2021
doctorgram Stethoscope DES-I
K210736 · DQD
Gv Concepts
Cardiovascular · 138d
Cleared Jul 27, 2021
Us2.v1
K210791 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 133d
Cleared Jul 27, 2021
1Derful HS, 1Derful HT
K210884 · EIH
1derful, Inc.
Dental · 124d
Cleared Jul 27, 2021
PET VCAR
K211247 · KPS
GE Medical Systems SCS
Radiology · 92d
Cleared Jul 27, 2021
Volpara Imaging Software
K211279 · LLZ
Volpara Health Technologies Limited
Radiology · 91d
Cleared Jul 27, 2021
Senhance Surgical System
K211325 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jul 27, 2021
aPROMISE
K211655 · LLZ
Exini Diagnostics AB
Radiology · 60d
Cleared Jul 27, 2021
Fixxsure Anterior Lumbar Plate and Screw System
K211932 · KWQ
Oak Tree Engineering, LLC
Orthopedic · 35d
Cleared Jul 27, 2021
Aveir Introducer
K211989 · DYB
Abbott Medical
Cardiovascular · 29d