9 results
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18ms
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Sources: EU EUDAMED, US FDA
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TIANXIE
FDA 510(k)
FDA Class 2
·General Hospital
DD BIO Z AND DD BIO Z - TRANSPA
FDA 510(k)
FDA Class 2
·Dental
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Injury
·ETHICON, INC·Product code GAM·January 9, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 20, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·September 12, 2025
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·October 8, 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