10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
USS VAS
FDA 510(k)
FDA Class 2
·Orthopedic
CEREC3 VITABLOCKS
FDA 510(k)
FDA Class 2
·Dental
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·April 17, 2013
VENTILATOR TUBING LONG LENGTH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·March 21, 2011
PT2 GUIDE WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQX·June 18, 2008
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015