18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IROOT BP PLUS
FDA 510(k)
FDA Class 2
·Dental
Zavation
FDA UDI
Zavation LLC·00842166146198·eZspand PLIF/T-PLIF 9x27x15°, 7-11.5mm
Zavation
FDA UDI
Zavation LLC·00842166146495·eZspand PLIF/T-PLIF 9x27x15°, 10.5-15mm
Zavation
FDA UDI
Zavation LLC·00842166146341·eZspand PLIF/T-PLIF 9x27x15°, 8.5-13mm
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
ECAT PET SCANNER
FDA 510(k)
FDA Class 2
·Radiology
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
FDA 510(k)
FDA Class 2
·Cardiovascular
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 25, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 21, 2006
METRX(TM) SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 23, 2025
S3 EX - 3005
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 3, 2013
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·September 4, 2014
FUSION PRE-LOADED OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·May 4, 2011
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 2016
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