16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE XTREME INJECTOR OPTION
FDA 510(k)
FDA Class 2
·Radiology
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
FDA 510(k)
FDA Class 2
·Hematology
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
FDA 510(k)
FDA Class 2
·Orthopedic
PB560 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 22, 2011
PB560 VENTILATOR X1
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015
VANGUARD CR FEMORAL 70 MM RIGHT-INTERLOK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 2, 2017
VANGUARD CR TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 2, 2017
VANGUARD SERIES A STANDARD PATELLA
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 2, 2017
BIOMET REGENENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·February 2, 2017
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 23, 2013
CALAXO - UNKNOWN
FDA Adverse Event
Other
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·July 25, 2008
ZIMMER NATURAL NAIL SYSTEM CORTICAL SCREW
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSB·May 3, 2011
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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