21 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOCARDIA, INC.
FDA registration
BIOCARDIA, INC.·3 products·🇺🇸 United States
Morph AccessPro Steerable Introducer
FDA UDI
BIOCARDIA, INC.·00866749000240·
Morph AccessPro Steerable Introducer
FDA UDI
BIOCARDIA, INC.·00866749000257·
Avance Steerable Introducer
FDA UDI
Biocardia, Inc.·00850007221003·Cardiovascular catheter introducer
Avance Steerable Catheter
FDA UDI
Biocardia, Inc.·00850007221027·Cardiovascular catheter introducer
Helical Infusion Catheter
FDA UDI
Biocardia, Inc.·00866749000271·Catheter, percutaneous
Avance Steerable Introducer
FDA UDI
Biocardia, Inc.·00850007221010·Cardiovascular Catheter introducer
Morph DNA
FDA UDI
Biocardia, Inc.·00866749000295·Guide Catheter
Morph Universal Deflectable Guide Catheter
FDA UDI
BIOCARDIA, INC.·00866749000202·
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE 6F
FDA Adverse Event
Injury
·BIOCARDIA, INC.·Product code DQY·March 25, 2010
BIOCARDIA MORPH ACCESSPRO
FDA Adverse Event
Injury
·BIOCARDIA, INC.·Product code DYB·June 14, 2012
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE
FDA Adverse Event
Injury
·BIOCARDIA, INC.·Product code DQX·October 30, 2009
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER
FDA Adverse Event
Injury
·BIOCARDIA, INC.·Product code DQO·June 22, 2011
BIOCARDIA MORPH ACCESSPRO STEERABLE INTRODUCER
FDA Adverse Event
Malfunction
·BIOCARDIA, INC.·Product code DYB·July 26, 2013
MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
FDA Adverse Event
Injury
·BIOCARDIA, INC.·Product code DQY·February 17, 2015
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
FDA Recall
Terminated
·Biocardia, Inc.·Product code DYB·March 3, 2014
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
FDA Recall
Terminated
·Biocardia, Inc.·Product code DYB·March 3, 2014
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Biocardia, Inc.·April 2, 2014
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Biocardia, Inc.·April 2, 2014
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
FDA Recall
Terminated
·Biocardia, Inc.·Product code DYB·February 7, 2014