21 results · 22ms · Sources: EU EUDAMED, 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