16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECHOSTIM FACET TIP
FDA 510(k)
FDA Class 2
·Anesthesiology
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOTEQUE VAGINAL DILATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FR CLERMONT FERRAND
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 3, 2012
MERCY HSP PITTSBURGH PA 1
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·May 7, 2009
HCSG/HENDRICK MED/ABLNE TX 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010
DIDECO COMPACTFLO EVO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·January 16, 2013
DIDECO COMPACTFLO EVO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code KFM·December 13, 2012
DIDECO COMPACTFLO EVO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012
NELLCOR OXIMAN N-65
FDA Adverse Event
Malfunction
·SANMINA-SCI SYSTEMS·Product code DQA·April 11, 2013
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 19, 2011
VACORA BIOPSY INSTRUMENT
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·June 19, 2008
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 25, 2011
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 25, 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