18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HSV STRAW
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIOMED 15 DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI 3-D HEAD FOR TI CLICKX SCREWS
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNH·May 3, 2013
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 5, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 3, 2011
AML HIGH OFFSET LG STAT 15.0MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 18, 2013
S-ROM M HEAD 36MM +0
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 21, 2012
PINNACLE MTL INS NEUT36IDX60OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 21, 2012
S-ROM M HEAD 36MM +0
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 21, 2012
PINNACLE MTL INS NEUT36IDX60OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 21, 2012
PINNACLE 100 ACET CUP 60MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·October 28, 2011
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 28, 2011
PINNACLE MTL INS NEUT36IDX60OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 28, 2011
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 26, 2013
PINN CAN BONE SCREW 6.5MMX45MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·August 26, 2013
PINN CAN BONE SCREW 6.5MMX35MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·August 26, 2013
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