26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVANCE UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HI-TORQUE CONNECT
FDA UDI
ABBOTT VASCULAR INC.·08717648175015·Hi-Torque Connect Flex Guide Wire .018" 195 cm
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040132937·Zirlux TR A3.5 98x14mm
KENNETH BLACK NEW YORK
FDA UDI
FGX INTERNATIONAL INC.·00193033427880·
KENNETH BLACK NEW YORK
FDA UDI
FGX INTERNATIONAL INC.·00193033427897·
KENNETH BLACK NEW YORK
FDA UDI
FGX INTERNATIONAL INC.·00193033427903·
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 18, 2012
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM
FDA Enforcement
Class II
·Terminated·Abbott Vascular, Inc.·January 1, 2014
CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER (POCKET SIZE)
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code BSK·February 20, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INT'L LTD·Product code KWA·February 24, 2011
XELOS DR-T
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·March 12, 2008
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 6, 2013
M2A-MAGNUM 12/14 TPR 42-50 -3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 6, 2013
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 6, 2013
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 20, 2015
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 27, 2021
PERSONA TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 29, 2019
PERSONA BEARING COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 28, 2019