19 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANESTHESIA VENTILATOR CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
CUSTOM STERILE PROCEDURE TRAYS-MULTI
FDA 510(k)PINNACLE MTL INS NEUT28IDX46OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 3, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·November 2, 2012
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 23, 2010
UNK - PLATES: LCP MINI FRAGMENT
FDA Adverse Event
Malfunction
·Product code HRS·September 30, 2021
UNK - PLATES: LCP MINI FRAGMENT
FDA Adverse Event
Malfunction
·Product code HRS·September 30, 2021
UNK - CONSTRUCTS: MINI-MODULAR SYSTEM PLATE/SCREWS
FDA Adverse Event
Malfunction
·Product code HRS·September 30, 2021
UNK - SCREWS: MATRIXRIB
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·September 30, 2021
UNK - PLATES: MATRIXRIB
FDA Adverse Event
Malfunction
·Product code HRS·September 30, 2021
UNK - PLATES: MATRIXRIB
FDA Adverse Event
Malfunction
·Product code HRS·September 30, 2021
UNK - PLATES: LCP MINI FRAGMENT
FDA Adverse Event
Malfunction
·Product code HWC·September 30, 2021
UNK - SCREWS: CORTEX
FDA Adverse Event
Injury
·Product code HWC·September 30, 2021
UNK - PLATES: MATRIXRIB
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·September 30, 2021
UNK - PLATES: LCP MINI FRAGMENT
FDA Adverse Event
Injury
·Product code HRS·September 30, 2021
UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
FDA Adverse Event
Malfunction
·Product code HRS·September 30, 2021
UNK - PLATES: MATRIXRIB
FDA Adverse Event
Malfunction
·Product code HRS·September 30, 2021
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020