18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
EMINENT SPINE INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065685·INTRAORAL ELASTICS 4,5 oz 1/8" brown
exsalt PT7 Contact Layer; 8" x 16"
FDA UDI
Exciton Technologies Inc·07540127000406·The exsalt™ PT7 Contact Layer (PT7) is indicate...
Ultracheck
FDA UDI
Statcorp Medical·10841522100918·BP CUFF,MIDMARK, REUSABLE, 1T, ADULT, HP, EA
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
FDA 510(k)
FDA Class 2
·Hematology
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
FDA 510(k)
FDA Class 2
·Radiology
TGS UKA SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL INC.·Product code HSX·May 15, 2014
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 5, 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