10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
FDA 510(k)
FDA Class 2
·Neurology
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 26, 2025
V 2.0 FIRM EXT PEBAX
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·April 17, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 19, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·June 17, 2008
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018