16 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TERUMO AV FISTULA NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Zavation
FDA UDI
Zavation LLC·00197157010195·MODULAR SHANK DRIVER
Zavation
FDA UDI
Zavation LLC·00197157010225·MODULAR SHANK DRIVER
Zavation
FDA UDI
Zavation LLC·00197157010218·MODULAR SHANK DRIVER
Zavation
FDA UDI
Zavation LLC·00197157010171·MODULAR SHANK DRIVER
Zavation
FDA UDI
Zavation LLC·00197157010201·MODULAR SHANK DRIVER
Zavation
FDA UDI
Zavation LLC·00197157010188·MODULAR SHANK DRIVER
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
FDA 510(k)
FDA Class 2
·Cardiovascular
BOUNDARY SPECIALTY GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 29, 2010
UNIFY QUADRA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 31, 2012
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014