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
15721–15744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2021
MiPACS HTML5 Web Viewer
K212984 · LLZ
Lead Technologies, Inc.
Radiology · 56d
Cleared Nov 11, 2021
Nitrile Examination Glove (Powder free, Blue)
K212497 · LZA
Jiangsu Jinlian Medical Technology...
General Hospital · 94d
Cleared Nov 11, 2021
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy...
K212532 · LZA
Crdlight Optoelectronic Technology...
General Hospital · 92d
Cleared Nov 11, 2021
EnSite X EP System
K213364 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Nov 10, 2021
LTV2 Series Ventilators
K201082 · CBK
Vyaire Medical, Inc.
Anesthesiology · 566d
Cleared Nov 10, 2021
Venen-trainer (Model: FM150, SFM90)
K203746 · JOW
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 323d
Cleared Nov 10, 2021
inVisionOS
K210344 · LLZ
Precisionos Technology, Inc.
Radiology · 278d
Cleared Nov 10, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K210779 · LZA
Shandong Shangwei Medical Products...
General Hospital · 240d
Cleared Nov 10, 2021
VSP® Orthopedics System
K211244 · PBF
3D Systems
Orthopedic · 198d
Cleared Nov 10, 2021
Lunit INSIGHT CXR Triage
K211733 · QFM
Lunit, Inc.
Radiology · 159d
Cleared Nov 10, 2021
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7...
K211975 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 138d
Cleared Nov 10, 2021
ESSENZ Patient Monitor
K212003 · DXJ
Livanova Deutschland, GmbH
Cardiovascular · 135d
Cleared Nov 10, 2021
eKuore Pro 4T - REF EP0098
K212013 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 135d
Cleared Nov 10, 2021
Reverso
K212107 · GEI
Intelis Instruments , Ltd.
General & Plastic Surgery · 127d
Cleared Nov 10, 2021
Disposable Automatic Core Biopsy Instrument
K212284 · KNW
Suzhou Leapmed Healthcare Corporation
Gastroenterology & Urology · 112d
Cleared Nov 10, 2021
AlignRT Plus
K212583 · IYE
Vision Rt, Ltd.
Radiology · 86d
Cleared Nov 10, 2021
More-Cell-System
K212659 · PMU
Agency For Medical Innovations GmbH
Obstetrics & Gynecology · 79d
Cleared Nov 10, 2021
RTapp
K212887 · LLZ
Segana, Inc.
Radiology · 61d
Cleared Nov 10, 2021
Diode laser therapy system
K212978 · GEX
Beijing Unt Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Nov 10, 2021
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
K213089 · FPA
Ivenix, Inc.
General Hospital · 47d
Cleared Nov 10, 2021
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity...
K213389 · JWH
Conformis, Inc.
Orthopedic · 26d
Cleared Nov 09, 2021
BESPA Charcot System
K202326 · HWC
Bespa Global, LLC
Orthopedic · 449d
Cleared Nov 09, 2021
Medical Face Masks, Model Name:MY020003
K211165 · FXX
Huizhou Jie Bai Purification Co., Ltd.
General Hospital · 204d
Cleared Nov 09, 2021
FreedomEdge(R) Syringe Infusion System
K211206 · FRN
Repro-Medical System, Inc., Dba Koru...
General Hospital · 201d