Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64009–64032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2005
CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE
K051694 · MEG
Medical Device Manufacturer...
General Hospital · 181d
Cleared Dec 21, 2005
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
K051864 · GWF
The Magstim Company , Ltd.
Neurology · 166d
Cleared Dec 21, 2005
SEASPINE VBR SYSTEM
K052170 · MQP
Seaspine, Inc.
Orthopedic · 134d
Cleared Dec 21, 2005
DENTAPLAST HOT, MODEL 16-XXX
K052780 · EBI
Bredent-Products For the Dental...
Dental · 79d
Cleared Dec 21, 2005
HSINER JET NEBULIZER, MODEL HS-31100
K052811 · CAF
Hsiner Co., Ltd.
Anesthesiology · 78d
Cleared Dec 21, 2005
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES
K052923 · LYZ
Great Glove (China), Inc.
General Hospital · 64d
Cleared Dec 21, 2005
NITRILE BLUE POWDER FREE EXAMINATION GLOVE
K052956 · LZA
Great Glove Sdn Bhd
General Hospital · 61d
Cleared Dec 21, 2005
MASIMO SET RAD-8 PULSE OXIMETER
K053269 · DQA
Masimo Corporation
Anesthesiology · 28d
Cleared Dec 21, 2005
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
K053404 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 14d
Cleared Dec 21, 2005
VAPORMAX II
K053457 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 8d
Cleared Dec 21, 2005
NOVOFINE 32G TIP
K053470 · FMI
Novo Nordisk, Inc.
General Hospital · 7d
Cleared Dec 20, 2005
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
K052135 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 137d
Cleared Dec 20, 2005
VITALOGIK
K052288 · DSI
Mennen Medical , Ltd.
Cardiovascular · 119d
Cleared Dec 20, 2005
BRAIN VIEWRX VIEWER, VERSION 1.0
K052467 · LLZ
Kyron Clinical Imaging, Inc.
Radiology · 103d
Cleared Dec 20, 2005
PANA-SPRAY
K052700 · EFB
Nsk America Corp.
Dental · 83d
Cleared Dec 20, 2005
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL...
K052772 · KGO
Barriermed Glove Co.
General Hospital · 78d
Cleared Dec 20, 2005
BRECOMP
K052779 · EBF
Bredent-Products For the Dental...
Dental · 78d
Cleared Dec 20, 2005
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K052810 · MBI
Scandius Biomedical, Inc.
Orthopedic · 77d
Cleared Dec 20, 2005
VITROS CA 19-9
K052889 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 68d
Cleared Dec 20, 2005
GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES
K052922 · LYZ
Great Glove (China), Inc.
General Hospital · 63d
Cleared Dec 20, 2005
ASCENT PIT & FISSURE SEALANT
K053089 · EBC
CAO Group, Inc.
Dental · 48d
Cleared Dec 20, 2005
AMBU MARK IV BABY RESUSCITATOR
K053142 · BTM
Ambu A/S
Anesthesiology · 41d
Cleared Dec 20, 2005
MYNEB NEBULIZER, MODEL RDD100
K053203 · CAF
Respironics New Jersey, Inc.
Anesthesiology · 34d
Cleared Dec 20, 2005
THERAKNIT GARMENT ELECTRODE
K053214 · GXY
Neurotron Medical
Neurology · 33d