9 results
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34ms
·
Sources: EU EUDAMED, US FDA
BARD PERIPHERAL BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ReLine
FDA UDI
Nuvasive, Inc.·00195377072719·RELINE C Ti Rod, 4.0x400mm Straight
MUCOTROL CONCENTRATED ORAL GEL WAFER
FDA 510(k)
FDA Unclassified
·Unknown
Dental porcelain powder
FDA 510(k)
FDA Class 2
·Dental
ETHILON NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAO·February 4, 2013
N/A
FDA Adverse Event
Malfunction
·ASCENT·Product code HRX·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
FDA Enforcement
Class II
·Terminated·Med Tec Inc·June 10, 2020
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).
FDA Enforcement
Class II
·Terminated·Peters Surgical·October 1, 2014