21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890123770·Zirlux Shading Liquid - Dentin, 0M3, 100ml
G-aenial™
FDA UDI
Gc America Inc.·14548161328692·G-aenial Universal Injectable AE, Dispensing Ti...
G-aenial™
FDA UDI
Gc America Inc.·D0470123771·G-aenial Universal Injectable AE, Dispensing Ti...
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033398463·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033398487·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033398470·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033398432·
6Pin 3-Lead ECG Host Cable,Def-P
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004136·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033398456·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033398449·
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
FDA 510(k)
FDA Class 2
·General Hospital
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
FDA 510(k)
FDA Class 1
·General Hospital
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·August 28, 2018
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 23, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 20, 2013
HAEMOFILTRATION SET
FDA Adverse Event
Malfunction
·HAEMOTRONICS SPA·Product code FJK·March 9, 2011
VECTRA GENISYS
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code IPF·March 7, 2008
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION·Product code FRN·October 27, 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