3,659 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Quantum TTC
FDA UDI
COOK INCORPORATED·00827002225466·Quantum TTC Pyloric Balloon Dilator
Quantum TTC
FDA UDI
COOK INCORPORATED·00827002225503·Quantum TTC Pyloric Balloon Dilator
Quantum TTC
FDA UDI
COOK INCORPORATED·00827002225473·Quantum TTC Pyloric Balloon Dilator
Quantum TTC
FDA UDI
COOK INCORPORATED·00827002225510·Quantum TTC Pyloric Balloon Dilator
Quantum TTC
FDA UDI
COOK INCORPORATED·00827002229983·Quantum TTC Pyloric Balloon Dilator
Quantum TTC
FDA UDI
COOK INCORPORATED·00827002225527·Quantum TTC Pyloric Balloon Dilator
Quantum TTC
FDA UDI
COOK INCORPORATED·00827002225480·Quantum TTC Pyloric Balloon Dilator
Quantum TTC
FDA UDI
COOK INCORPORATED·00827002225497·Quantum TTC Pyloric Balloon Dilator
ENCODER, J6, HIP 190-00137
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·September 19, 2018
RIO SURGICAL ARM
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 19, 2016
FILMARRAY PNEUMO PANEL
FDA Adverse Event
Malfunction
·BIOFIRE DIAGNOSTICS, LLC·Product code QDP·May 14, 2026
J6 ARM FOR HIP WITH QD
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·November 2, 2016
J6 ARM FOR HIP WITH QD
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·July 1, 2016
J6 ARM FOR HIP WITH QD
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 15, 2016
Respiratory Panel
FDA classification
FDA Class 2
·Respiratory Panel
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018
SDP INC.
FDA registration
SDP INC.·15 products·🇨🇦 Canada
MDP SRL
FDA registration
MDP SRL·1 product·🇮🇹 Italy
ADP HEALTH LIMITED
FDA registration
ADP HEALTH LIMITED·3 products·🇺🇸 United States
AVCOO
FDA UDI
ADP HEALTH LIMITED·00850073128183·1) TENS
The device is designed to be used for t...