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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon.
FDA Recall
Terminated
·Sterilmed Inc·Product code NKU·August 8, 2008
Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
FDA classification
FDA Class 2
·Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
GPC
FDA UDI
GPC MEDICAL LIMITED·08904400203080·Universal Allen Key
KNU, LLC
FDA registration
KNU, LLC·2 products·🇺🇸 United States
NAU S.P.A.
FDA registration
NAU S.P.A.·3 products·🇮🇹 Italy
KNU, LLC
FDA registration
KNU, LLC·2 products·🇺🇸 United States
HAPAD NEUROMA PADS
FDA UDI
HAPAD INC·00082147001867·
NUK USA LLC
FDA registration
NUK USA LLC·7 products·🇺🇸 United States
Knu Healthcare / Knu Comfort
FDA UDI
Knu, LLC·G53301070·Mobile Healthcare Recliner - Locking Back
Knu Healthcare / Knu Comfort
FDA UDI
Knu, LLC·G53301670·Mobile Healthcare Recliner - Locking Back, Fold...
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G53350170·Mobile Healthcare Recliner
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G533ZL620·ZG Lift Recliner with Dual Fold Down Arms
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G53311420·Mobile Healthcare Recliner - Dual Removable Arm...
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G53310670·Mobile Healthcare Recliner - Fold Down Arm
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G53342170·Mobile Healthcare Recliner - Cable Release
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G53340170·Mobile Healthcare Recliner
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G533ZX620·Zero Gravity Lift Exam Recliner with Dual Fold ...
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G533ZX670·Zero Gravity Lift Exam Recliner with Single Fol...
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G5337P180·Power Lift Exam Recliner - Locking Back
La-Z-Boy Healthcare | Knu Comfort
FDA UDI
Knu, LLC·G53331170·Mobile Healthcare Recliner - Locking Back