12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NUTROMAT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780521402·CODMAN® Peel-Away Catheter Introducer 12.5FR.
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780537403·CODMAN® Peel-Away Catheter Introducer
CODMAN
FDA UDI
Cerenovus, Inc.·20886704042737·CODMAN Peel-Away Catheter Introducer 12.5 FR.
Corplex P / Theracor P / Allacor P
FDA 510(k)
FDA Unclassified
·Unknown
QUATTRO GL SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
CODMAN
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES PRODUCTION CORPORATION·Product code GYK·August 26, 2022
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 24, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·November 5, 2012
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 10, 2010
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
FDA Enforcement
Class II
·Terminated·Polymer Technology Systems, Inc.·March 11, 2020
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018