14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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X-FACTOR DISCS
FDA 510(k)
FDA Class 1
·Microbiology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18025001·
Coverlet®
FDA UDI
BSN MEDICAL, INC.·00035664003036·COVERLET ELASTIC OVAL 1.25" TAN 100
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277114365·Nordt Micro Fracture Set
FacetLINK MI
FDA UDI
LINKSPINE, INC.·00817329025658·FacetLINK MI Set
Grappler Interference Screw System
FDA UDI
Paragon 28, Inc.·00889795128393·Grappler Interference Screw System, Screw, Ø8 m...
Tenodesis Screw System
FDA UDI
Paragon 28, Inc.·00889795053879·Grappler PEEK Interference Screw 8 x 25mm
DEPUY SIGMA CR-F FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
X-POSURE SYSTEM VERSION 2 RAD
FDA 510(k)
FDA Class 2
·Radiology
TI PARALLEL CONNECTOR 5.0MM/6.0MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code MDI·May 9, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 19, 2012
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 26, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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