20 results
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83ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tri-Staple 2.0 Reinforced Reload
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Centronail Titanium Universal Femoral Nailing System
FDA UDI
ORTHOFIX SRL·18032937169207·CANNULATED RIGID REAMER
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034308154·Cancellous Screw, Cannulated, D=7,3mm, L=70mm,
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·June 2, 2005
POWEREASE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
INSTINCT JAVA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·November 14, 2024
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 2, 2016
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 23, 2011
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·June 17, 2013
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·September 12, 2018
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
CPS SHORT ANCHOR PLUG 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 27, 2022
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018