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
80809–80832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2001
CANNULATED SCREW SYSTEM
K003496 · HTN
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 08, 2001
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
K003512 · HQC
A.R.C. Laser AG
Ophthalmic · 86d
Cleared Feb 08, 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · DRB
Medtronic Vascular
Cardiovascular · 84d
Cleared Feb 08, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
K003586 · MVN
Ciba-Geigy Corp.
Ophthalmic · 80d
Cleared Feb 08, 2001
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
K003627 · FMI
Exelint International, Co.
General Hospital · 76d
Cleared Feb 08, 2001
BIOLOK SCREW, BIOSTEON SCREW
K003641 · HWC
Biocomposites, Ltd.
Orthopedic · 73d
Cleared Feb 08, 2001
TAPER-FIT TOTAL HIP SYSTEM
K003666 · JDI
Corin USA
Orthopedic · 72d
Cleared Feb 08, 2001
ENVIVE MINIFORMS
K003843 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 58d
Cleared Feb 08, 2001
2010 PLUS HOLTER FOR WINDOWS
K003940 · MLO
Agilent Technologies
Cardiovascular · 49d
Cleared Feb 08, 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · ESW
Rusch Intl.
Gastroenterology & Urology · 31d
Cleared Feb 08, 2001
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
K010190 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 17d
Cleared Feb 08, 2001
PROTRACT PRESS FIT HIP STEM-HA COATED
K010241 · LPH
Stelkast Company
Orthopedic · 14d
Cleared Feb 07, 2001
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
K000776 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 334d
Cleared Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 180d
Cleared Feb 07, 2001
HOLY DRAGON ACUPUNCTURE NEEDLES
K002910 · MQX
Anc Import & Export Co. , Ltd.
General Hospital · 142d
Cleared Feb 07, 2001
ULTRASOUND SCANNER TYPE 2101
K003041 · IYO
B & K Medical A/S
Radiology · 131d
Cleared Feb 07, 2001
BIO-EYE II ORBITAL IMPLANT
K003338 · HPZ
Integrated Orbital Implants, Inc.
Ophthalmic · 105d
Cleared Feb 07, 2001
ANCURE LLIAC BALLOON CATHETER
K003495 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 86d
Cleared Feb 07, 2001
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
K003533 · JOJ
Steritec Products, Inc.
General Hospital · 83d
Cleared Feb 07, 2001
ADAPTERS WITH X-COATING
K003604 · DTL
Terumo Cardiovascular Systems Corp.
Cardiovascular · 78d
Cleared Feb 07, 2001
THERMOFX MESH
K003757 · JEY
Bionx Implants, Ltd.
Dental · 63d
Cleared Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K010064 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 07, 2001
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
K010130 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 22d