11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENConnect 40 mm Screw Cap to ENPlus Adapter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306822513·Truswell Implant Insertion Trocar with trocar T...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306822520·Truswell Trocar 5mmx95mm 2,Tip
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
HEARTWAY POWER CHAIR, P23
FDA 510(k)
FDA Class 2
·Physical Medicine
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 6, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·June 26, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 20, 2011
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
FDA Enforcement
Class I
·Terminated·TELEFLEX-MORRISVILLE·November 13, 2019
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020