19 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 CERULOPLASMIN
FDA 510(k)
FDA Class 2
·Immunology
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 24, 2015
IMBIBE BONE MARROW ASPIRATION SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
KINETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·December 16, 2011
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 26, 2012
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 6, 2015
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 11, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 11, 2013
UNKNOWN PREFILL
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code NZW·May 28, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 13, 2011
PORTEX® ULTRAPERC® SINGLE DILATOR TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·October 17, 2019
ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0°, RETRO
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·November 21, 2018
ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWT·November 21, 2018
ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-0
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 2018
ANATOMICAL SHOULDER FRACTURE, HUMERAL STEM, 7-130
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 2018
PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·October 14, 2019
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 24, 2014
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