16 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INTRAVASCULAR CATHETER SECURMENT DEVICE
FDA 510(k)
FDA Class 1
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799301·MANUMED ACTIVE WRIST LEFT SILVER XS
DURA BLUE STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
EFILM WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 50ML LL CLEAR 14GA 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 18, 2021
SYRINGE 50ML LL CLEAR 14GA 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 16, 2021
TPRLC 133 T1 PPS SO 12X144MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·January 11, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 18, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 3, 2014
G7 HI-WALL E1 LINER 36MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·August 28, 2019
G7 OSSEOTI MULTIHOLE 58MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 28, 2019
CER BIOLOXD OPTION HD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·August 28, 2019
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021