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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
40105–40128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2013
S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K132768 · IYN
Sonoscape Company Limited
Radiology · 30d
Cleared Oct 04, 2013
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
K132861 · IYN
Samsung Medison Co., Ltd.
Radiology · 22d
Cleared Oct 04, 2013
SMARTSITE VIALSHIELD
K132863 · LHI
Yukon Medical, LLC
General Hospital · 22d
Cleared Oct 04, 2013
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
K132905 · BRZ
Arteriocyte Medical Systems, Inc.
General Hospital · 18d
Cleared Oct 03, 2013
AMCAD-UT DETECTION MODEL 2.0
K122536 · LLZ
Lin & Associates, LLC
Radiology · 409d
Cleared Oct 03, 2013
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
K122557 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 407d
Cleared Oct 03, 2013
CLEANSER ROOT CANAL
K130180 · KJJ
Cerkamed Wojciech Pawlowski
Dental · 251d
Cleared Oct 03, 2013
OCCLUSION PERFUSION CATHETER
K130525 · DQY
Advanced Catheter Therapies, Inc.
Cardiovascular · 217d
Cleared Oct 03, 2013
DISPOSABLE SILICONE FOLEY CATHETER
K130908 · EZL
Guangdong Baihe Medical Technology...
Gastroenterology & Urology · 185d
Cleared Oct 03, 2013
FINGERTIP PULSE OXIMETER
K130947 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 182d
Cleared Oct 03, 2013
LEDEX
K131042 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 171d
Cleared Oct 03, 2013
NEO KNEE SYSTEM
K131368 · JWH
Pipeline Orthopedics
Orthopedic · 143d
Cleared Oct 03, 2013
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW,...
K131435 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 136d
Cleared CT Oct 03, 2013
MODIFIED FLOWGATE BALLOON GUIDE CATHETER
K131492 · DQY
Concentric Medical, Inc.
Cardiovascular · 133d
Cleared Oct 03, 2013
THERMOCHEM HT-2000
K131583 · MLW
Thermasolutions, Inc.
Gastroenterology & Urology · 125d
Cleared Oct 03, 2013
COLONGLIDE(R) LUBRICANT
K131617 · KMJ
Pediatric Pharmaceuticals, Inc.
General Hospital · 122d
Cleared Oct 03, 2013
ANYSCAN-S SPECT IMAGING SYSTEM
K131625 · KPS
Absolute Imaging Solutions
Radiology · 121d
Cleared Oct 03, 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Oct 03, 2013
AVAFLEX VERTEBRAL BALLOON SYSTEM
K131824 · HRX
Care Fusion
Orthopedic · 105d
Cleared Oct 03, 2013
NATUS WARMETTE BLANKET AND DUAL CABINETS
K132110 · LGZ
Natus Nicolet Ireland, Ltd.
General Hospital · 86d
Cleared Oct 03, 2013
BEAUTIFIL BULK FLOWABLE
K132141 · EBF
Shofu Dental Corporation
Dental · 84d
Cleared Oct 03, 2013
DICOM VIDEO
K132183 · LMA
Bar Code Computer, Ltd.
Radiology · 80d
Cleared Oct 03, 2013
DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL...
K132199 · GEI
Deroyal Industries, Inc.
General & Plastic Surgery · 79d
Cleared Oct 03, 2013
EVEREST SPINAL SYSTEM
K132361 · MNI
K2m, Inc.
Orthopedic · 65d