10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
FDA 510(k)
FDA Class 2
·Anesthesiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111116742·CUFF BLADDER BULB VALVE CHILD
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HARDYDISK LEVOFLOXACIN, 5MCG
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
PENEVAC, MEGADYNE E-Z CLEAN
FDA Adverse Event
Malfunction
·I.C. MEDICAL·Product code GEI·April 3, 2013
BREEZE2
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 11, 2011
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT CO·Product code IRT·June 16, 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