10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRANIOCUT
FDA 510(k)
FDA Class 2
·Neurology
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
FDA 510(k)
FDA Class 2
·Cardiovascular
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
FDA 510(k)
FDA Class 2
·Radiology
CADD MS3 CARTRIDGES
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 20, 2022
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 20, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011
NELLCOR N-550 PULSE OXIMETER
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code DQA·March 28, 2008
CENTRIMAG BLOOD PUMP
FDA Adverse Event
Injury
·THORATEC SWITZERLAND GMBH·Product code KFM·April 27, 2021
VERSYS FM HD 28X012/14
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 4, 2022
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