21 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHOCOR KNEE SYSTEM BASIC
FDA 510(k)
FDA Class 2
·Physical Medicine
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450207086·
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BOLTON PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SUSTAIN 4X13 HA CYLINDER IMPLANT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·December 30, 1998
CENTRAX BI-POLAR CUP 32X54MM
FDA Adverse Event
Malfunction
·HOWMEDICA INC.·Product code KWB·November 26, 1997
CENTRAX BI-POLAR CUP 32X60MM
FDA Adverse Event
Malfunction
·HOWMEDICA INC.·Product code KWB·December 13, 1997
CENTRAX BI-POLAR CUP 32X52MM
FDA Adverse Event
Malfunction
·HOWMEDICA INC.·Product code KWB·February 5, 1998
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 7, 1997
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·October 19, 2005
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·July 13, 2004
LINOX S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·May 3, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 27, 2014
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 18, 2011
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·August 8, 2013
S-SCORT TEN
FDA Adverse Event
Death
·SSCOR, INC.·Product code JCX·October 13, 1999
STAR
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LZS·January 3, 2019
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·February 20, 2014
TRI-STAPLE 2.0
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·December 8, 2022
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016