11 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
FDA 510(k)
FDA Class 2
·Immunology
Comforsil
FDA UDI
PRIM S.A.·08431082070841·Thick toe separator, Silicone
ACUMED
FDA UDI
Acumed LLC·10806378041884·Small Ratchet Handle with QR Connection
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
FDA 510(k)
FDA Class 2
·Hematology
SI JOINT FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN - UNSPECIFIED BY THE COMPLAINANT
FDA Adverse Event
Injury
·COOK BIOTECH, INCORPORATED·Product code PAG·April 3, 2014
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·October 16, 2012
ECHELON 60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2010
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter
FDA Enforcement
Class II
·Terminated·SteriGear, LLC·July 2, 2014
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter
FDA Recall
Terminated
·SteriGear, LLC·Product code FCN·January 11, 2011
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021