13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
FDA 510(k)
FDA Class 2
·Immunology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450391037·
SEED LINK
FDA 510(k)
FDA Class 2
·Radiology
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
HEMICAP/UNICAP RESURFACING PROSTHESIS
FDA Adverse Event
Other
·ARTHROSURFACE, INC.·Product code HSD·December 7, 2012
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·February 20, 2013
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·February 20, 2013
PORTEX® ULTRAPERC® SINGLE DILATOR TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·October 17, 2019
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013
ANEURX AAADVANTAGE BIFURCATED HYDRO
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 23, 2008
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·April 13, 2011
PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·October 14, 2019
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