16 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Audit MicroControls Control FD Assayed Chemistry, Level 1
FDA UDI
AALTO SCIENTIFIC·B085K0311100·
APEX MODULAR ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED
Zavation
FDA UDI
Zavation LLC·00842166178519·Set of blades 110mm lateral
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131100·Rocker, One Piece
HammerTech
FDA UDI
FUSION ORTHOPEDICS, LLC·00819034027095·HT PEEK Driver Petite
CRYSTAL-EEG MODEL 15
FDA 510(k)
FDA Class 2
·Neurology
M2A ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
PFC SIGMARP CV TB/IN S3 12.5
FDA Adverse Event
Injury
·DEPUY IRELAND ? REG. # 9616671·Product code NJL·April 2, 2013
V.A.C THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·March 22, 2011
GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL
FDA Adverse Event
Injury
·GUIDANT CARDIAC SURGERY·Product code DXC·April 18, 2008
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016