8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·April 17, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·June 10, 2008
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·April 11, 2011
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