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
62977–63000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2006
ENTAKE STANDARD AND SAFETY PEG SYSTEM
K061021 · KNT
Conmedcorp
Gastroenterology & Urology · 15d
Cleared Apr 27, 2006
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1
K051419 · DWJ
Inditherm Medical
Cardiovascular · 330d
Cleared Apr 27, 2006
STAXX XD SYSTEM
K052670 · MQP
Spine Wave, Inc.
Orthopedic · 212d
Cleared Apr 27, 2006
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
K053078 · ISD
Ergoline GmbH
Physical Medicine · 176d
Cleared Apr 27, 2006
AMPLATZER NOODLEWIRE GUIDEWIRE
K053187 · DQX
Aga Medical Corp.
Cardiovascular · 163d
Cleared Apr 27, 2006
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
K053491 · DQY
Penumbra, Inc.
Cardiovascular · 133d
Cleared Apr 27, 2006
VIVAWAVE MICROWAVE ABLATION SYSTEM
K053535 · NEY
Valleylab
General & Plastic Surgery · 129d
Cleared Apr 27, 2006
STRYKER SCOPE/INSTRUMENT HOLDER
K060085 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 106d
Cleared Apr 27, 2006
TULIP DISPOSABLE CANNULAS
K060089 · QPB
Cell Bio-Systems, Inc.
General & Plastic Surgery · 105d
Cleared Apr 27, 2006
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
K060390 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 72d
Cleared Apr 27, 2006
INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
K060413 · KNW
Intact Medical Corporation
Gastroenterology & Urology · 70d
Cleared Apr 27, 2006
VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX
K060441 · EIH
Vident
Dental · 65d
Cleared Apr 27, 2006
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER...
K060753 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 37d
Cleared Apr 27, 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL...
K060877 · FGE
Cordis Corp.
Gastroenterology & Urology · 27d
Cleared Apr 27, 2006
VELSCOPE
K060920 · NXV
Led Medical Diagnostics, Inc.
Dental · 23d
Cleared Apr 26, 2006
ECP HEALTH SYSTEM, MODEL 2005
K052611 · DRN
Ecp Health, Inc.
Cardiovascular · 216d
Cleared Apr 26, 2006
PREFTEST PROFESSIONAL SUITE
K052929 · LIL
Limestone Technologies, Inc.
Gastroenterology & Urology · 189d
Cleared Apr 26, 2006
C. DIFF QUIK CHEK
K053572 · MCB
Techlab, Inc.
Microbiology · 125d
Cleared Apr 26, 2006
DRI-STAT ACID PHOSPHATASE REAGENT
K053612 · CKB
Beckman Coulter, Inc.
Chemistry · 120d
Cleared Apr 26, 2006
COOLGARD 3000
K060308 · NCX
Alsius Corp.
Neurology · 78d
Cleared Apr 26, 2006
DR DISPOSABLE PROPHY ANGLE MODEL H310
K060377 · EGS
Dental Resources
Dental · 71d
Cleared Apr 26, 2006
ASP TITANIUM
K060392 · MQX
Sedatelec
General Hospital · 70d
Cleared Apr 26, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML,...
K060447 · LON
Becton, Dickinson & CO
Microbiology · 64d
Cleared Apr 26, 2006
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
K060710 · HWC
Zimmer, Inc.
Orthopedic · 41d