18 results · 21ms · Sources: EU EUDAMED, US FDA

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RM3 RENAL PRESERVATION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

TABLETOP SHIELD

FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175002247·Shield, Tabletop, Standard, .5" Lead

Entuit Thrive LP

FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356894·

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

XPS 3000 SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·November 2, 2010

IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 5, 2009

VERTEX RECONSTRUCTION SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·July 23, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·April 2, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·March 31, 2016

MUSTANG¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·April 9, 2013

NEXGEN IMPACTOR/EXTRACTOR REPLACEMENT JAW

FDA Adverse Event
Malfunction ·ZIMMER INC·Product code MBH·February 15, 2011

INSIGNIA ULTRA

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

MICRODEBRIDER 1898200T IGS M4

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025