FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13393–13416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2022
4CIS Chiron Spinal Fixation System
K203233 · NKB
Solco Biomedical Co., Ltd.
Orthopedic · 576d
Cleared Jun 01, 2022
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
K210107 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 502d
Cleared Jun 01, 2022
freeflex+ Transfer Adapter
K212445 · LHI
Fresenius Kabi AG
General Hospital · 300d
Cleared Jun 01, 2022
DeltaFil, DeltaFil Conditioner
K213201 · EMA
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 245d
Cleared Jun 01, 2022
Purgo
K213753 · FRA
Aeroclean Technologies, LLC
General Hospital · 183d
Cleared Jun 01, 2022
AneuGuide
K213838 · PZO
ArteryFlow Technology Co., Ltd.
Neurology · 174d
Cleared Jun 01, 2022
BeneVision Central Monitoring System
K220058 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 146d
Cleared Jun 01, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with...
K220488 · LZA
Anhui Zhong Lian Latex Gloves...
General Hospital · 99d
Cleared Jun 01, 2022
TriMed Ripcord Device
K220650 · HTN
TriMed, Inc.
Orthopedic · 86d
Cleared Jun 01, 2022
CoreLink Navigation Instruments
K220973 · OLO
Corelink, LLC
Orthopedic · 58d
Cleared Jun 01, 2022
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
K221002 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 58d
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