16 results
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27ms
·
Sources: EU EUDAMED, US FDA
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FAST-FIX
FDA UDI
Smith & Nephew, Inc.·03596010388148·SMALL STERILIZATION TRAY WITH MAT
...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112030·Tap, 5.5 mm
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 25, 2025
INTER-VIAL
FDA 510(k)
FDA Class 2
·General Hospital
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 30, 2023
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 13, 2025
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 6, 2023
NEXIVA 20GA 1.00IN HF Y
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 7, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 19, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 2, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2008
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018