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
15361–15384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2021
Vy Spine ClariVy Cervical IBF System
K212715 · ODP
Vy Spine, LLC
Orthopedic · 116d
Cleared Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K212776 · NLG
Innovative Health, LLC
Cardiovascular · 110d
Cleared Dec 20, 2021
First Relief
K212859 · NHI
Dyansys, Inc.
Neurology · 103d
Cleared Dec 20, 2021
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K213031 · NCX
Zoll Circulation, Inc.
Neurology · 90d
Cleared Dec 20, 2021
AspenMed+
K213076 · LZC
Aspen Glove Sdn. Bhd.
General Hospital · 88d
Cleared Dec 20, 2021
EchoGo Core (2.0)
K213275 · QIH
Ultromics Limited
Radiology · 81d
Cleared Dec 20, 2021
TR BAND Radial Compression Device
K213531 · DXC
Terumo Medical Corporation
Cardiovascular · 45d
Cleared Dec 19, 2021
ATOZ Mini-Screw
K210559 · OAT
Mk Meditech, Inc.
Dental · 297d
Cleared Dec 18, 2021
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
K211457 · LZA
Ammex Corporation
General Hospital · 221d
Cleared Dec 18, 2021
USA Gloves Nitrile Powder Free Exam Gloves
K211624 · LZA
Usa Gloves
General Hospital · 205d
Cleared Dec 18, 2021
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace...
K212932 · KCT
Nobel Biocare Services AG
General Hospital · 94d
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213048 · LZA
Huayuan Medical Technology(Shangqiu)...
General Hospital · 87d
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213051 · LZA
Yunnan Huazhiyuan Medical Technology...
General Hospital · 87d
Cleared Dec 17, 2021
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and...
K193081 · QEP
Rheonix, Inc.
Microbiology · 773d
Cleared Dec 17, 2021
Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
K200943 · FLL
Circa Scientific, LLC
Cardiovascular · 618d
Cleared Dec 17, 2021
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood...
K203424 · DTZ
Qura S.R.L
Cardiovascular · 392d
Cleared Dec 17, 2021
NObreath®
K203695 · MXA
Bedfont Scientific, Ltd.
Chemistry · 364d
Cleared Dec 17, 2021
Donagamex Blue Performance Protective Gown
K203821 · QPC
Dong Nai Garment Corporation (Donagamex)
General Hospital · 353d
Cleared Dec 17, 2021
MED RF 4000
K210077 · ONQ
F Care Systems USA, LLC
General & Plastic Surgery · 339d
Cleared Dec 17, 2021
Topwide Surgical Face Mask
K210102 · FXX
Topwide (Hubei) Medical Products...
General Hospital · 337d
Cleared Dec 17, 2021
Revitive Medic Coach (Model Number 5575AQ)
K210825 · NGX
Actegy , Ltd.
Physical Medicine · 273d
Cleared Dec 17, 2021
PDO Max Suture with Dual Needle
K210871 · NEW
Pdo Max, Inc.
General & Plastic Surgery · 268d
Cleared Dec 17, 2021
Sterile Syringe for Single Use
K210914 · FMF
Jiangsu Suyun Medical Material Co., Ltd.
General Hospital · 263d
Cleared Dec 17, 2021
Libby IAAA v1.0
K210931 · LLZ
Dyad Medical, Inc.
Cardiovascular · 263d