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
71977–72000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2003
BALL RECORDING ELECTRODE/STIMULATION PROBE
K030517 · GZK
Viasys Healthcare, Inc.
Neurology · 163d
Cleared Aug 01, 2003
GUGLIELMI DETACHABLE COIL (GDC)
K031049 · HCG
Boston Scientific, Target
Neurology · 121d
Cleared Aug 01, 2003
DBT, DYNAMIC BUBBLE TRAP
K031323 · DTM
Convergenza AG
Cardiovascular · 98d
Cleared Aug 01, 2003
ISOLETTE INFANT INCUBATOR, MODEL C2000E
K031387 · FMZ
Hill-Rom Manufacturing, Inc.
General Hospital · 91d
Cleared Aug 01, 2003
XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
K031451 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 86d
Cleared Aug 01, 2003
MEDRAD MANUAL SYRINGE LOADER
K031483 · DXT
Medrad, Inc.
Cardiovascular · 81d
Cleared Aug 01, 2003
SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT...
K031532 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 78d
Cleared Aug 01, 2003
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
K031561 · DQK
Ge Medical Systems Information...
Cardiovascular · 74d
Cleared Aug 01, 2003
MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
K031578 · HCG
Micrus Corp.
Neurology · 73d
Cleared Aug 01, 2003
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
K031582 · MNW
Nihon Seimitsu Sokki Co., Ltd.
Gastroenterology & Urology · 72d
Cleared Aug 01, 2003
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED),...
K031625 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 66d
Cleared Aug 01, 2003
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
K031641 · JCT
Vascular Architects, Inc.
General & Plastic Surgery · 66d
Cleared Aug 01, 2003
SK MED M201 PLUS MIXER
K031707 · BZR
Sk Med
Anesthesiology · 60d
Cleared Aug 01, 2003
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE...
K031768 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 53d
Cleared Aug 01, 2003
DENTISEPTIC HPC
K031851 · EFB
Bethel, Inc.
Dental · 46d
Cleared Aug 01, 2003
EMBRACE WET-BOND RESTORATIVE MATERIAL
K031877 · EBF
Pulpdent Corporation
Dental · 45d
Cleared Aug 01, 2003
AURORA DS
K031988 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 35d
Cleared Aug 01, 2003
AURORA SR
K031993 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 35d
Cleared Aug 01, 2003
MODIFICATION TO THERMACOOL TC SYSTEM
K032088 · GEI
Thermage, Inc.
General & Plastic Surgery · 25d
Cleared Aug 01, 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 22d
Cleared Aug 01, 2003
IQ HYDROPHILIC GUIDE WIRE
K032183 · DQX
Boston Scientific Corp
Cardiovascular · 15d
Cleared Aug 01, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
K032202 · LLZ
Planar Systems, Inc.
Radiology · 14d
Cleared Jul 31, 2003
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
K021362 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 457d
Cleared Jul 31, 2003
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F...
K030671 · DQY
Medtronic Vascular
Cardiovascular · 150d