12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Uni-FuZe-C Bone Strip
FDA 510(k)
FDA Class 2
·Orthopedic
GEBAUER'S INSTANT ICE
FDA 510(k)
FDA Unclassified
·Unknown
Arterial Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·November 14, 2009
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·December 16, 2009
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·November 3, 2014
SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·August 24, 2011
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·July 11, 2013
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·February 1, 2010
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
INRATIO
FDA Adverse Event
Injury
·BIOSITE INCORPORATED·Product code JPA·January 29, 2010
INRATIO2
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·March 2, 2010