21 results
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20ms
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Sources: EU EUDAMED, US FDA
MICROJET QUARK, MODEL U100 OR U40
FDA 510(k)
FDA Class 2
·General Hospital
PECTUS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036011109·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521472·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521380·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521434·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521458·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130070·Rocker, One Piece
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521441·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033521465·
PECTUS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00888233005173·
PECTUS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036131692·
CYSTOSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MUSCLE STIMULATOR SA-100
FDA 510(k)
FDA Class 2
·Physical Medicine
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·March 20, 2013
HUDSON DUAL-LIMB CIRCUIT, PEDIATRIC
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·February 3, 2011
MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - C
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code KYB·March 14, 2008
SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·April 2, 2019
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 2, 2019
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
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