12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERRAD NX STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
STERRAD® NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811081·Grooved Director, 23cm
Verteview®
FDA UDI
ATLAS SPINE, INC.·M681VSS0421160·4.2mm x 16mm Self Drilling Screw
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356528·
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 9, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·March 29, 2011
CONTAK RENEWAL TR 2
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NKE·May 8, 2008
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