15 results
·
29ms
·
Sources: EU EUDAMED, US FDA
MODEL Q55XT POWERED TREADMILL
FDA 510(k)
FDA Class 1
·Physical Medicine
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024139251·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024139268·
SF BROTH
FDA 510(k)
FDA Class 1
·Microbiology
CARE ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code LPH·January 3, 2018
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 10, 2014
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 11, 2010
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012
VERSYS HIP SYSTEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·November 15, 2022
DUROM US ACET CMPNT 52/46 L
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·July 28, 2021
FEMORAL HEAD +0X32MM DIA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 20, 2021
METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·May 25, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 28, 2020