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
67057–67080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2005
READMYHEART
K042814 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 86d
Cleared Jan 06, 2005
CARDIOFAX CE, MODEL PEA-1110K
K042827 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 86d
Cleared Jan 06, 2005
IMPLANT SCIENCES CORP, MODEL HDR-4140
K042864 · KXK
Implant Sciences Corp.
Radiology · 80d
Cleared Jan 06, 2005
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Jan 06, 2005
GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
K042938 · KDI
Gambro Renal Products
Gastroenterology & Urology · 73d
Cleared Jan 06, 2005
ELITY 70 X-RAY
K043136 · EHD
Dental X-Ray E.U.
Radiology · 55d
Cleared Jan 06, 2005
CADSTREAM VERSION 4.0
K043216 · LLZ
Confirma, Inc.
Radiology · 45d
Cleared Jan 06, 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 31d
Cleared Jan 06, 2005
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K043535 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jan 05, 2005
MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
K043088 · HAW
Medtronic Surgical Navigation...
Neurology · 58d
Cleared Jan 05, 2005
LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
K043273 · GEI
Valleylab
General & Plastic Surgery · 40d
Cleared Jan 05, 2005
VERSYO.DIRECT
K043295 · EBI
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Jan 05, 2005
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · HWE
Synthes (Usa)
Orthopedic · 35d
Cleared Jan 05, 2005
IMT.LAB
K043360 · LLZ
Pie Medical
Radiology · 29d
Cleared Jan 05, 2005
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K043552 · DSY
Vascutek, Ltd.
Cardiovascular · 9d
Cleared Jan 04, 2005
PHARMGUARD TOOLBOX, MODEL G6000782
K042432 · FRN
Medex, Inc.
General Hospital · 118d
Cleared Jan 04, 2005
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K043127 · CAC
Haemonetics Corp.
Anesthesiology · 53d
Cleared Jan 04, 2005
HORIZON MEDICAL IMAGING
K043146 · LLZ
Mckesson Medical Imaging Company
Radiology · 50d
Cleared Jan 03, 2005
FUNHALER, MODEL FH 101
K042546 · CAF
Infamed , Ltd.
Anesthesiology · 105d
Cleared Jan 03, 2005
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K042678 · NBW
Bionime Corporation
Chemistry · 96d
Cleared Jan 03, 2005
IXL-II DIABETES MANAGEMENT SYSTEM
K042792 · LZG
Insulet Corporation
General Hospital · 89d
Cleared Jan 03, 2005
NOVA-PULSE
K043302 · EBZ
Nova Ranger, Inc.
Dental · 34d
Cleared Jan 03, 2005
BC PLUS
K043562 · KLE
Vericom Co., Ltd.
Dental · 7d
Cleared Dec 30, 2004
BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
K033210 · FAD
Bioteque Corp.
Gastroenterology & Urology · 454d