10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AggreGuide A-100 ADP
FDA 510(k)
FDA Class 2
·Hematology
PIONEER PLUS CATHETER, MODEL PLUS 120
FDA 510(k)
FDA Class 2
·Cardiovascular
VENTRIO HERNIA PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DR FOG TREATED SPONGE, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·July 29, 2021
INVICTUS SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025
CRIMPER F/TRANSV-ONNECTORS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWN·June 21, 2013
ETS FLEX ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 27, 2011
VITROS CHEMISTRY PRODUCTS VALP REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·September 18, 2008
BD¿ NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022