FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77785–77808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2001
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
K010918 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 149d
Cleared Aug 23, 2001
STRAUMANN GBR SYSTEM
K011698 · JEY
Institut Straumann AG
Dental · 83d
Cleared Aug 23, 2001
RADIUS NEXT GENERATION GUIDEWIRE
K011759 · OCY
Radius Medical Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 23, 2001
HI-WAVE
K011762 · EBI
Denplus, Inc.
Dental · 77d
Cleared Aug 23, 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231 · EIH
Jeneric/Pentron, Inc.
Dental · 38d
Cleared Aug 23, 2001
LUXACORE/LUXACORE DUAL
K012307 · EBF
Dmg USA, Inc.
Dental · 31d
Cleared Aug 23, 2001
PERMACEM / PERMACEM DUAL
K012316 · EMA
Dmg USA, Inc.
Dental · 31d
Cleared Aug 23, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012347 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 23, 2001
MODIFICATION TO VASCULAR CLOSURE DEVICE
K012362 · GDW
Std Mfg., Inc.
General & Plastic Surgery · 29d
Cleared Aug 23, 2001
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · GBM
Astra Tech, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 23, 2001
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · DWF
Medtronic Vascular
Cardiovascular · 16d
Cleared Aug 23, 2001
GE LOGIQ A100 MP, MODEL 2272413
K012560 · IYO
General Electric Co.
Radiology · 15d
Cleared Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE...
K012567 · MID
Corgenix, Inc.
Immunology · 14d
Cleared Aug 22, 2001
SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
K001853 · FMI
Medtech Systems, Inc.
General Hospital · 429d
Cleared Aug 22, 2001
LIGHTLAS 532 PHOTOCOAGULATOR
K010372 · HQF
Lightmed Corp.
Ophthalmic · 196d
Cleared Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418 · LTT
Dade Behring, Inc.
Microbiology · 191d
Cleared Aug 22, 2001
CRYOPLAN SYSTEM
K011073 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 135d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604 · LNI
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Aug 22, 2001
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
K011749 · LYY
Sempermed USA, Inc.
General Hospital · 83d
Cleared Aug 22, 2001
MONARCH INFLATION SYRINGE
K011811 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 72d
Cleared Aug 22, 2001
BRIDGE FX
K011817 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 72d
Cleared Aug 22, 2001
RADIOGRAPHIC MARKERS
K011856 · NEU
Encore Orthopedics, Inc.
General & Plastic Surgery · 70d
Cleared Aug 22, 2001
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
K011941 · FRO
The Kendall Company
General & Plastic Surgery · 62d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · GEI
Ortho Development Corp.
General & Plastic Surgery · 44d