13 results
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27ms
·
Sources: EU EUDAMED, US FDA
AUTOMATED PERIMETERS
FDA 510(k)
FDA Class 1
·Ophthalmic
CORDIS SLALOM PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
FDA 510(k)
FDA Class 2
·Hematology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·October 17, 2024
MLRY-HD POR FMRL 7X140MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·May 9, 2014
PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 10, 2007
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code FRN·June 24, 2020
BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 27, 2018
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018