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
21169–21192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2019
InMode System with the Morpheus8 (Fractora) Applicators
K192695 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 92d
Cleared Dec 27, 2019
Xcam
K192700 · EHD
Hdx Will Corp.
Radiology · 92d
Cleared Dec 27, 2019
Volumetric Specimen Imager
K192939 · MWP
Clarix Imaging
Radiology · 70d
Cleared Dec 27, 2019
True 3D Viewer Software
K193149 · LLZ
Echopixel, Inc.
Radiology · 44d
Cleared Dec 27, 2019
UroNav System
K193403 · LLZ
Invivo Corporation
Radiology · 21d
Cleared Dec 26, 2019
iHelmet Hair Growth System
K190467 · OAP
Slinph Technologies Co., Ltd.
General & Plastic Surgery · 303d
Cleared Dec 26, 2019
TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
K190884 · GDW
Datascope Corp.
General & Plastic Surgery · 266d
Cleared Dec 26, 2019
Temporary Fixation Pins
K192768 · JDW
Eisertech, LLC
Orthopedic · 87d
Cleared Dec 26, 2019
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset...
K193050 · LZO
Zimmer GmbH
Orthopedic · 55d
Cleared Dec 24, 2019
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter...
K192135 · DQY
MicroVention, Inc.
Neurology · 139d
Cleared Dec 23, 2019
Mini and Micro Fragments Reconstruction System – GMReis
K182718 · HRS
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 451d
Cleared Dec 23, 2019
Neodent Instrument Kit Cases
K190665 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 283d
Cleared Dec 23, 2019
Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use...
K190736 · LZA
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 277d
Cleared Dec 23, 2019
Disposable Powder Free Nitrile Examination Glove, Tested For Use With...
K190860 · LZA
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 265d
Cleared Dec 23, 2019
RIST Cath Radial Access Long Sheath
K191551 · DQY
Rist Neurovascular, Inc.
Neurology · 194d
Cleared Dec 23, 2019
MAXReach Laser Probe
K191846 · HQB
Vortex Surgical, Inc.
Ophthalmic · 166d
Cleared Dec 23, 2019
Arthrex Univers Revers Modular Glenoid System
K191960 · PHX
Arthrex, Inc.
Orthopedic · 153d
Cleared Dec 23, 2019
Arm Blood Pressure Monitor
K192023 · DXN
Truly Instrument Limited
Cardiovascular · 147d
Cleared Dec 23, 2019
Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use...
K192104 · LZA
Medline Industries, Inc.
General Hospital · 140d
Cleared Dec 23, 2019
BioCode Respiratory Pathogen Panel (RPP)
K192485 · OCC
Applied BioCode, Inc.
Microbiology · 104d
Cleared Dec 23, 2019
EZ-TRAX Containment Device
K192487 · KCT
K1 Medical, LLC
General Hospital · 103d
Cleared Dec 23, 2019
Trigon™ Ti Stand-Alone Wedge Fixation System
K192645 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 90d
Cleared Dec 23, 2019
RelieforMe TENS/EMS Device Model UPK-GE01
K192733 · IPF
Umeheal , Ltd.
Physical Medicine · 87d
Cleared Dec 23, 2019
3M Attest Steam Chemical Integrator
K193254 · JOJ
3M Company
General Hospital · 27d