22 results
·
31ms
·
Sources: EU EUDAMED, US FDA
NA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 7, 2012
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
FDA 510(k)
FDA Class 3
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450780756·
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 13, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·February 12, 2026
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033567487·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033567500·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033567494·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033567463·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033567470·
Bathtub
FDA UDI
Ropox A/S·05707581004131·
Bathtub
FDA UDI
Ropox A/S·05707581000386·
ALOKA SSD-5500 WITH KI AND A-SMA
FDA 510(k)
FDA Class 2
·Radiology
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ISOFLEX S
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 13, 2008
ARCHITECT CA 125 II REAGENT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LTK·May 27, 2014
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
FDA Enforcement
Class II
·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019