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

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176,076 results
53689–53712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2009
PRIMADO
K083112 · HBC
Nakanishi, Inc.
Neurology · 190d
Cleared Apr 29, 2009
I-FIX SYSTEM
K083586 · DZE
Dentis Co., Ltd.
Dental · 146d
Cleared Apr 29, 2009
ROC LUMBAR PLATING SYSTEM
K090228 · MNH
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared Apr 29, 2009
OPAL SEAL
K090355 · DYH
Ultradent Products, Inc.
Dental · 77d
Cleared Apr 29, 2009
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292
K090569 · FRC
3M Company
General Hospital · 58d
Cleared Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION...
K090594 · CFN
Siemens Healthcare Diagnostics
Immunology · 55d
Cleared Apr 29, 2009
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
K090638 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 50d
Cleared Apr 29, 2009
EMPRESS DIRECT
K090701 · EBF
Ivoclar Vivadent, Inc.
Dental · 43d
Cleared Apr 29, 2009
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
K091017 · FZP
Cardica, Inc.
General & Plastic Surgery · 20d
Cleared Apr 29, 2009
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
K091084 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 14d
Cleared Apr 28, 2009
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
K082038 · BTR
Clarus Medical, LLC
Anesthesiology · 285d
Cleared Apr 28, 2009
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
K083203 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 180d
Cleared Apr 28, 2009
SWABCAP
K083508 · QBP
Excelsior Medical Corp.
General Hospital · 153d
Cleared Apr 28, 2009
TRAXODENT
K083695 · MVL
Premier Dental Products Co.
Dental · 134d
Cleared Apr 28, 2009
SYNGO BREVIS
K090038 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Apr 28, 2009
BCI WW1021 PC APPLICATION
K090205 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 90d
Cleared Apr 28, 2009
PIONEER LUMBAR PLATE SYSTEM
K090222 · KWQ
Pioneer Surgical Technology
Orthopedic · 88d
Cleared Apr 28, 2009
MTA PROTECTIVE SHEET
K090778 · FTM
Xylos Corporation
General & Plastic Surgery · 36d
Cleared Apr 28, 2009
MPS ACACIA POWER INJECTABLE INFUSION SET
K090809 · FPA
Mps Acacia
General Hospital · 34d
Cleared Apr 28, 2009
ORTHOSTAT
K091121 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 11d
Cleared CT Apr 27, 2009
STEERABLE GUIDE CATHETER
K083793 · DRA
Evalve, Inc.
Cardiovascular · 126d
Cleared Apr 27, 2009
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
K083931 · LYZ
Quantum Co., Ltd.
General Hospital · 143d
Cleared Apr 27, 2009
DS N95 SURGICAL MASKS AND FLAT SURGICAL
K090131 · MSH
Shanghai Dasheng Health Products
General Hospital · 96d
Cleared Apr 27, 2009
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
K090176 · MQP
Nuvasive, Inc.
Orthopedic · 94d