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
66865–66888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2005
BEAM MODULATOR, MODEL 4513 332 8000
K042794 · IYE
Elekta , Ltd.
Radiology · 116d
Cleared Jan 31, 2005
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K042937 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 98d
Cleared Jan 31, 2005
AMADEUS II EPIKERATOME
K043150 · HNO
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 77d
Cleared Jan 31, 2005
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
K043173 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 76d
Cleared Jan 31, 2005
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631,...
K043270 · HSB
Zimmer GmbH
Orthopedic · 66d
Cleared Jan 31, 2005
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
K043346 · KWS
Genesis Medical LLC
Orthopedic · 56d
Cleared Jan 31, 2005
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
K043460 · JIX
Olympus America, Inc.
Chemistry · 47d
Cleared Jan 31, 2005
IN EXAM INTRAORAL DENTAL X-RAY SYSTEM
K050019 · EHD
Kavo America
Radiology · 26d
Cleared Jan 31, 2005
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
K050026 · JIX
Roche Diagnostics
Chemistry · 25d
Cleared Jan 31, 2005
DYNAFLO BYPASS GRAFT
K050049 · DSY
Bard Peripheral Vascular, Inc.
Cardiovascular · 21d
Cleared Jan 31, 2005
CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
K050069 · GEX
Cutera, Inc.
General & Plastic Surgery · 19d
Cleared Jan 31, 2005
R605 FACS COLLIMETER
K050092 · IZW
Omega Medical Imaging, Inc.
Radiology · 17d
Cleared Jan 31, 2005
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
K050121 · HRS
Zimmer, Inc.
Orthopedic · 12d
Cleared Jan 28, 2005
PACHYCAM
K041841 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 204d
Cleared Jan 28, 2005
MEDTRONIC STRATAVARIUS
K041992 · JXG
Medtronic Neurosurgery
Neurology · 189d
Cleared Jan 28, 2005
INFANT FEEDING TUBE
K042112 · KNT
Marian Medical, Inc.
Gastroenterology & Urology · 176d
Cleared Jan 28, 2005
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
K042278 · MQN
Oral Osteodistraction, L.P.
Dental · 158d
Cleared Jan 28, 2005
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
K042321 · KWT
Biomet Manufacturing Corp
Orthopedic · 155d
Cleared Jan 28, 2005
POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING...
K043014 · LYY
Shijiazhuang Tillotson Rubber...
General Hospital · 87d
Cleared Jan 28, 2005
NEUROMONICS TINNITUS TREATMENT
K043274 · KLW
Neuromonics Pty, Ltd.
Ear, Nose, Throat · 63d
Cleared Jan 28, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
K043290 · LNH
Neurognostics, Inc.
Radiology · 60d
Cleared Jan 28, 2005
20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB
K043430 · LLZ
Totoku Electric Co., Ltd.
Radiology · 46d
Cleared Jan 28, 2005
RADIN, MODEL V 3.0
K043483 · LLZ
Sohard AG
Radiology · 42d
Cleared Jan 28, 2005
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
K043487 · FDF
Aizu Olympus Co., Ltd.
Gastroenterology & Urology · 42d