23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII
ArgenZ HT+ 98x12 ML D3B
FDA UDI
ARGEN CORPORATION, THE·D818130307·Dental porcelain/ceramic restoration kit
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925012653·SCHEER PLASTIC TUBE INSERTER
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·November 5, 2013
CONMED
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·May 3, 2002
CONMED
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·May 3, 2002
CONMED
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·May 3, 2002
GELSCAN, MODEL 1206
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DAVOL ARTHROVENT OUTFLOW TUBING
FDA 510(k)
FDA Class 2
·Orthopedic
NDM
FDA Adverse Event
Malfunction
·ASPEN LABORATORIES, INC.·Product code GEI·July 23, 1999
CONMED
FDA Adverse Event
Malfunction
·ASPEN LABORATORIES, INC.·Product code GEI·July 23, 1999
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
CONMED ESU HANDPIECE CAT # 130307
FDA Adverse Event
Malfunction
·CONMED CORP.·Product code GEI·August 6, 1997
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·May 22, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 9, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 22, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·September 12, 2013
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·November 20, 2013