10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYKNEE CUTTING BLOCKS
FDA 510(k)
FDA Class 2
·Orthopedic
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
Medline
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389028018·FENESTRATED DRAPE, 24 X 36
SYNTHES METALLIC SPIKED WASHERS
FDA 510(k)
FDA Class 2
·Orthopedic
URETEROSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC.·Product code OOE·April 30, 2013
GENESYS HTA PROCERVA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MNB·September 16, 2014
BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·May 18, 2011
CATH. GUIDE 6F 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA63DRCSH
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012