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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71377–71400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 31, 2003
COACH 888
K030758 · INI
Wheelchair & Scooter Express
Physical Medicine · 142d
Cleared Jul 31, 2003
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
K031309 · INI
Kuann Dah Industry Co., Ltd.
Physical Medicine · 98d
Cleared Jul 31, 2003
RSV (RADIOLOGY SYSTEM VISIODENT
K031448 · EHD
Visiodent SA
Radiology · 85d
Cleared Jul 31, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K031480 · KRO
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Jul 31, 2003
SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
K031576 · IQI
Surgitech, Inc.
Physical Medicine · 72d
Cleared Jul 31, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
K031602 · LON
Dade Behring, Inc.
Microbiology · 71d
Cleared Jul 31, 2003
FILMLESS CLINIC
K031704 · LLZ
Connect Imaging, Inc.
Radiology · 59d
Cleared Jul 31, 2003
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829 · GJT
Instrumentation Laboratory CO
Hematology · 48d