8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A
FDA 510(k)
FDA Class 2
·Dental
'RAPID ONE' - PROPOXYPHENE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STERILE 5 IN 1 CONNECTORS
FDA 510(k)
FDA Class 2
·General Hospital
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAR·May 26, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 16, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 12, 2014
EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
FDA Enforcement
Class II
·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016