13 results
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29ms
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Sources: EU EUDAMED, US FDA
VITALCARE URETHRAL CATHETER RED RUBBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RUSCH MEMORY BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 27, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·February 14, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·April 4, 2008
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·December 12, 2012
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
UNKNOWN ENDO GIA SULU
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·July 22, 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