22 results
·
34ms
·
Sources: EU EUDAMED, US FDA
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
FDA 510(k)
FDA Class 2
·Cardiovascular
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517963·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517970·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518014·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518007·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517994·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518021·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517987·
MADA WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
3008261720-2023-013862
FDA Adverse Event
Injury
·JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA·Product code DZE·June 26, 2023
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 17, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013
QUICKSITE LV
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2011
DXTEND STAND PE CUP D38+3MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code HSD·March 14, 2008
AXIOM ARISTOS VX PLUS
FDA Adverse Event
Injury
·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 2, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 5, 2013
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