FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
13129–13152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2022
FROG Forceps Valve (VAL1-F1-100)
K221264 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 30d
Cleared May 31, 2022
Urea Nitrogen2
K203771 · CDQ
Abbott Ireland Diagnostics Division
Chemistry · 524d
Cleared May 31, 2022
IRRIGO Wound Wash Jet System
K210987 · FQH
Inopro, Inc.
General & Plastic Surgery · 425d
Cleared May 31, 2022
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
K211571 · OMP
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 375d
Cleared May 31, 2022
LuxCreo Clear Aligner System
K212680 · NXC
LuxCreo, Inc.
Dental · 280d
Cleared May 31, 2022
Disposable Powder Free Polyethylene Examination Gloves
K212699 · LZA
Mastermax Plastic (Huizhou), Ltd.
General Hospital · 279d
Cleared May 31, 2022
Bone Cement-Normal Viscosity
K212729 · LOD
Biomecanica Industria E Comerciode...
Orthopedic · 277d
Cleared May 31, 2022
Distal Access Catheter
K213065 · QJP
Guangzhou Easycess Medical Co.,Ltd
Neurology · 250d
Cleared May 31, 2022
Fibrillar Collagen Wound Dressing
K213341 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 236d
Cleared May 31, 2022
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
K213731 · KPS
Ever Fortune.Ai, Co., Ltd.
Radiology · 186d
Cleared May 31, 2022
Respire Clear
K214096 · LRK
Respire Medical, LLC
Dental · 154d
Cleared May 31, 2022
Upper Arm Electronic Blood Pressure Monitor(Model...
K220113 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 137d
Cleared May 31, 2022
eMurmur Heart AI
K220766 · DQD
Csd Labs GmbH
Cardiovascular · 76d
Cleared May 31, 2022
Rapid LVO
K221248 · QAS
Ischemaview, Inc.
Radiology · 29d
Cleared May 31, 2022
EchoNavigator R4.0
K221270 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared May 31, 2022
Liverty™ TIPS Access Set
K221440 · DYB
Bard Peripheral Vascular, Inc.
Cardiovascular · 14d
Cleared May 28, 2022
Blue Nitrile Examination Gloves Powder Free
K212584 · LZA
Amazing Rubber Products Pvt, Ltd.
General Hospital · 285d
Cleared May 28, 2022
Amazing+ Latex Examination Powder Free Gloves
K212597 · LYY
Amazing Rubber Products Pvt, Ltd.
General Hospital · 285d
Cleared May 28, 2022
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors,...
K213141 · LZA
Shen Wei (Usa), Inc.
General Hospital · 243d
Cleared May 27, 2022
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
K212268 · DQX
FMD Co., Ltd.
Cardiovascular · 311d
Cleared May 27, 2022
Single Use Hemoclip
K212669 · PKL
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 277d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838 · QJP
Penumbra, Inc.
Neurology · 262d
Cleared May 27, 2022
Aspire Cristalle
K212873 · MUE
Fujifilm Corporation
Radiology · 260d
Cleared May 27, 2022
CoLink PCR Plating System
K213698 · HRS
In2bones USA, LLC
Orthopedic · 185d