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

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176,076 results
69457–69480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2004
PERSONAL WARMING LUBRICANT
K040085 · HIS
Qualis, Inc.
Obstetrics & Gynecology · 95d
Cleared Apr 20, 2004
HAWK INTRAORAL CAMERA AND ACCESSORIES
K040116 · EIA
Dxm Co., Ltd.
Dental · 91d
Cleared Apr 20, 2004
COOLTOUCH
K040131 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Apr 20, 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · GWM
Integra LifeSciences Corporation
Neurology · 78d
Cleared Apr 20, 2004
PULPDENT VLC RESIN CEMENT
K040236 · EMA
Pulpdent Corporation
Dental · 78d
Cleared Apr 20, 2004
SONO TT ULTRASONIC FLOWCOMPUTER
K040909 · DPW
Em-Tec GmbH
Cardiovascular · 12d
Cleared Apr 19, 2004
BICARD MIXING SYSTEM
K030366 · FIN
Dialysis Systems, Inc.
Gastroenterology & Urology · 440d
Cleared Apr 19, 2004
MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY
K033005 · LLZ
Barco NV Barcoview
Radiology · 207d
Cleared Apr 19, 2004
MGD 2621P MEDICAL GREYSCALE DISPLAY
K033104 · LLZ
Barco NV Barcoview
Radiology · 203d
Cleared Apr 19, 2004
SENOGRAPHIC STEREO
K040125 · IZH
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Apr 19, 2004
VIATRONIX V3D COLON, REVISION 1.3
K040126 · LLZ
Viatronix, Inc.
Radiology · 90d
Cleared Apr 19, 2004
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE...
K040327 · MVO
Accu-Stat Diagnostics, Inc.
Toxicology · 69d
Cleared Apr 19, 2004
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
K040402 · MSD
AngioDynamics, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 19, 2004
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28,...
K040509 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 19, 2004
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
K040786 · DQX
Neometrics, Inc.
Cardiovascular · 21d
Cleared Apr 19, 2004
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
K040828 · LYZ
Zibo Borui Plastic & Rubber Products...
General Hospital · 19d
Cleared Apr 19, 2004
ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE
K040876 · LLZ
Vital Images, Inc.
Radiology · 14d
Cleared Apr 19, 2004
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
K040940 · EOQ
Olympus Corporation
Ear, Nose, Throat · 7d
Cleared Apr 16, 2004
CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY...
K032447 · HWC
Linvatec Biomaterials, Ltd.
Orthopedic · 252d
Cleared Apr 16, 2004
KATALYST RADIAL HEAD IMPLANT
K032806 · KWI
Kinetikos Medical, Inc.
Orthopedic · 220d
Cleared Apr 16, 2004
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
K032976 · KZE
Biovalve Technologies, Inc.
General Hospital · 205d
Cleared Apr 16, 2004
MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY
K033004 · LLZ
Barco NV Barcoview
Radiology · 204d
Cleared Apr 16, 2004
MGD 2621L MEDICAL GREYSCALE DISPLAY
K033103 · LLZ
Barco NV Barcoview
Radiology · 200d
Cleared Apr 16, 2004
IM TOTAL FEMUR
K033871 · JDI
Biomet, Inc.
Orthopedic · 126d