22 results · 34ms · Sources: EU EUDAMED, US FDA

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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