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
78289–78312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2001
DISPOSABLE VITRECTOMY LENS
K012096 · HJK
Ocular Instruments, Inc.
Ophthalmic · 50d
Cleared Aug 24, 2001
FLEX-NAILS
K012161 · HTY
Fixano SA
Orthopedic · 44d
Cleared Aug 24, 2001
ULTRACELL ABSORBENT STICK
K012196 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 42d
Cleared Aug 24, 2001
QUIK-CHECK OVULATION PREDICTOR
K012252 · CEP
ACON Laboratories, Inc.
Chemistry · 37d
Cleared Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · DIF
Randox Laboratories, Ltd.
Chemistry · 32d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 24, 2001
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
K012445 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 23d
Cleared Aug 23, 2001
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
K010772 · JAA
Imaging Services, Inc.
Radiology · 162d
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