12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
FDA 510(k)
FDA Class 2
·Cardiovascular
COPAN VIRAL TRANSYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
K-ASSAY C1-INA
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·April 16, 2013
CONSTELLATION
FDA Adverse Event
Malfunction
·ALCON LABORATORIES·Product code HQC·April 13, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 13, 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