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
21697–21720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2019
Okami Medical LOBO Vascular Occlusion System
K192083 · KRD
Okami Medical
Cardiovascular · 89d
Cleared Oct 30, 2019
Treace Medical Concepts (TMC) Plating System
K192504 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 48d
Cleared Oct 30, 2019
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and...
K192775 · PJB
Stereotaxis, Inc.
Cardiovascular · 30d
Cleared Oct 30, 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
K192783 · DQX
Scientia Vascular, LLC
Neurology · 30d
Cleared Oct 30, 2019
Atellica IM Total hCG (ThCG)
K192790 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2019
BRILLIANT COMPONEER
K191385 · EBF
Coltene/Whaledent AG
Dental · 159d
Cleared Oct 29, 2019
EmFace Device
K191855 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 111d
Cleared Oct 29, 2019
Compression Therapy Device Model LGT-2200SP
K191862 · IRP
Guangzhou Longest Science &...
Physical Medicine · 110d
Cleared Oct 29, 2019
MATRx Plus
K191925 · MNR
Zephyr Sleep Technologies
Dental · 103d
Cleared Oct 29, 2019
G21 SpaceFlex Hip
K192041 · MBB
G21, S.R.L.
Orthopedic · 90d
Cleared Oct 29, 2019
W Zirconia Implants
K192053 · DZE
Tav Medical , Ltd.
Dental · 90d
Cleared Oct 29, 2019
Game Ready GRPro 2.1 System
K192114 · IRP
Cool Systems, Inc. (Dba Game Ready)
Physical Medicine · 84d
Cleared Oct 29, 2019
Black Diamond Pedicle Screw System
K192121 · NKB
Osseus Fusion Systems
Orthopedic · 84d
Cleared Oct 29, 2019
Zimmer Biomet Universal Navigation System
K192133 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 83d
Cleared Oct 29, 2019
ROSA ONE Spine application
K192173 · OLO
Medtech S.A
Orthopedic · 78d
Cleared Oct 29, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · LCP
Ixensor Co, Ltd.
Chemistry · 60d
Cleared Oct 29, 2019
NexGen Anterior Cervical Plate System
K192494 · KWQ
Precision Spine
Orthopedic · 48d
Cleared Oct 28, 2019
3d Cage
K180347 · MAX
Fims Co., Ltd.
Orthopedic · 627d
Cleared Oct 28, 2019
HS AMICA devices family
K182605 · GEI
H.S Hospital Service S.P.A
General & Plastic Surgery · 402d
Cleared Oct 28, 2019
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
K191881 · LEJ
Kbl GmbH
General & Plastic Surgery · 105d
Cleared Oct 28, 2019
Straumann PUREloc abutments
K192029 · NHA
Institut Straumann AG
Dental · 90d
Cleared Oct 28, 2019
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
K192046 · QFO
DiaSorin, Inc.
Microbiology · 89d
Cleared Oct 28, 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673 · JOJ
3M Company
General Hospital · 32d
Cleared Oct 28, 2019
primeMidline Catheters
K192802 · PND
Pfm Medical, Inc.
General Hospital · 28d