18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO ZENIEVA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·October 9, 2009
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SUPERSTITCH VASCULAR SUTURING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·July 20, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·October 9, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·October 26, 2010
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·April 29, 2013
UNKNOWN DEPUY TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 3, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 25, 2008
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·July 20, 2009
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