17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
S5 CONTROL PANEL
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
M2A 38MM MODULAR HEAD+6MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 17, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2011
VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 19, 2008
SYRINGE 10ML REG PR SALINE 10ML FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·July 21, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 5, 2023
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