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
55081–55104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2008
LTM-BPS SURGICAL MESH
K082176 · FTM
Lifecell Corp.
General & Plastic Surgery · 105d
Cleared Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 100d
Cleared Nov 14, 2008
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
K082322 · GCJ
Covidien
General & Plastic Surgery · 93d
Cleared Nov 14, 2008
GENEX
K082381 · MQV
Biocomposites, Ltd.
Orthopedic · 87d
Cleared Nov 14, 2008
SYNGO IMAGING XS
K082430 · LLZ
Siemens AG Medical Solutions
Radiology · 84d
Cleared Nov 14, 2008
GDLS-200
K082434 · EBF
GC America, Inc.
Dental · 81d
Cleared Nov 14, 2008
C-QUEST
K082581 · KPS
Medx, Inc.
Radiology · 70d
Cleared Nov 14, 2008
CENTRICITY PACS WEB DIAGNOSTIC
K083018 · LLZ
Ge Healthcare Dynamic Imaging Solutions
Radiology · 36d
Cleared Nov 14, 2008
VERTEX RECONSTRUCTION SYSTEM
K083071 · KWP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 14, 2008
ULTRAWAVE III EX 1320
K083207 · GEX
Quanta System Spa
General & Plastic Surgery · 14d
Cleared Nov 13, 2008
LEP2000 THERAPY SYSTEM
K073689 · NHN
International Medical Instruments, Inc.
Physical Medicine · 321d
Cleared Nov 13, 2008
SERISCAFFOLD SURGICAL MESH
K080442 · FTL
Serica Technologies, Inc.
General & Plastic Surgery · 268d
Cleared Nov 13, 2008
SRI PLR GOWN
K080707 · FYA
Sri/Surgical Express
General Hospital · 246d
Cleared Nov 13, 2008
SRI LP GOWN
K080723 · FYA
Sri/Surgical Express, Inc.
General Hospital · 246d
Cleared Nov 13, 2008
BIOLOK MICRO-LOK IMPLANT SYSTEM
K081818 · DZE
BioHorizons Implant Systems, Inc.
Dental · 139d
Cleared Nov 13, 2008
RHAPSODY MRI
K082126 · LJT
Grantadler Corporation
General Hospital · 107d
Cleared Nov 13, 2008
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K082142 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 106d
Cleared Nov 13, 2008
BIOMET ANTERIOR LUMBAR PLATE
K082187 · KWQ
Ebi, L.P.
Orthopedic · 101d
Cleared Nov 13, 2008
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
K082392 · FEB
Advanced Sterilization Products
General Hospital · 86d
Cleared Nov 13, 2008
A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
K082734 · DXN
A&D Engineering, Inc.
Cardiovascular · 56d
Cleared Nov 13, 2008
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
K082803 · FFL
Percutaneous Systems, Inc.
Gastroenterology & Urology · 50d
Cleared Nov 13, 2008
BONART ART-L5 LED CORDLESS CURING LIGHT
K082971 · EBZ
Bonart Co., Ltd.
Dental · 38d
Cleared Nov 13, 2008
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
K083028 · NKB
Nuvasive, Inc.
Orthopedic · 34d
Cleared Nov 13, 2008
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K083035 · NZT
Sicel Technologies, Inc.
Radiology · 30d