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
47545–47568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2011
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
K103364 · JJY
Diamond Diagnostics, Inc.
Chemistry · 171d
Cleared May 06, 2011
UNIMAX SPECIMEN RETRIEVAL SYSTEM
K103510 · GCJ
Unimax Medical Systems, Inc.
General & Plastic Surgery · 158d
Cleared CT May 06, 2011
GE LUNAR VISCERAL FAT SOFTWARE
K103730 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 136d
Cleared May 06, 2011
LOTUS BLAKE ESTEEM SCOOTER
K103771 · INI
Letrix Power Hangzhou Pty, Ltd.
Physical Medicine · 130d
Cleared May 06, 2011
DIAMOND-FLEX(R) GRASPERS
K110257 · GCJ
Carefusion 2200, Inc.
General & Plastic Surgery · 98d
Cleared May 06, 2011
INDISTRIP GREEN
K110369 · JOJ
Indilab, Inc.
General Hospital · 87d
Cleared May 06, 2011
ASPIRA PERITONEAL DRAINAGE SYSTEM
K110396 · PNG
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared May 06, 2011
INNOVA WHEELCHAIR
K110788 · IOR
Columbia Medical Manufacturing, LLC
Physical Medicine · 45d
Cleared May 06, 2011
STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
K111015 · KGO
Cardinal Health, Inc.
General Hospital · 25d
Cleared May 06, 2011
EUNITY
K111164 · LLZ
Client Outlook, Inc.
Radiology · 10d
Cleared May 05, 2011
HLS KNEETEC SYSTEM
K094013 · JWH
Tornier
Orthopedic · 492d
Cleared May 05, 2011
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
K102263 · HGM
Mckesson Information Solutions, LLC
Obstetrics & Gynecology · 268d
Cleared May 05, 2011
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
K102342 · OUS
Microphage, Inc.
Microbiology · 260d
Cleared May 05, 2011
TITAN
K103760 · GWJ
Interacoustics A/S
Neurology · 133d
Cleared May 05, 2011
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C
K103835 · KWS
Howmedica Osteonics Corp.
Orthopedic · 126d
Cleared May 05, 2011
VENODYNE V810
K110358 · JOW
Microtek Medical, Inc.
Cardiovascular · 87d
Cleared May 05, 2011
ENSITE VELOCITY SYSTEM
K110549 · DQK
St Jude Medical
Cardiovascular · 69d
Cleared May 05, 2011
OWL RF PROBES
K110593 · GXI
Diros Technology, Inc.
Neurology · 64d
Cleared May 05, 2011
CENTRICITY PACS
K110875 · LLZ
Ge Healthcare
Radiology · 36d
Cleared May 05, 2011
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
K110963 · KWP
Globus Medical, Inc.
Orthopedic · 29d
Cleared May 05, 2011
IE-ZEN (IN CLEAR SERIES HEARING AID)
K110973 · KLW
Widex USA
Ear, Nose, Throat · 29d
Cleared May 05, 2011
ISSYS LP SPINAL FIXATION SYSTEM
K111099 · NKB
Custom Spine, Inc.
Orthopedic · 15d
Cleared May 05, 2011
RADIOVISION
K111102 · LLZ
Haas Software
Radiology · 15d
Cleared May 05, 2011
RELYX LUTING PLUS AUTOMIX
K111185 · EMA
3M Espe Dental Products
Dental · 8d