10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
POCKET BREATHALYZER. CONNECTABLES
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Plum
FDA UDI
ICU Medical, Inc.·10887787007722·ColorGard LATEX-FREE MIDLENGTH SECONDARY I.V. S...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848816·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
FDA 510(k)
FDA Class 1
·General Hospital
VECTORVISION TRAUMA
FDA 510(k)
FDA Class 2
·Neurology
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 11, 2013
LINOX S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·March 15, 2011
REFLOTRON PLUS V
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GKZ·May 22, 2008
ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Purple striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 4052448.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
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