20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
FDA 510(k)
FDA Class 2
·Cardiovascular
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958001925·600 Micron Disposable Diode Laser Lightguide, 6...
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992012460·LIPOSUCTION CANNULA DOUBLE TOTEM MODEL 2
BECKER GRATER 1
FDA UDI
The Wells Johnson Company·B458201246000·Cannula, Becker Grater 1, specify length, diame...
JPS JuniOrtho Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·December 19, 2019
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·December 19, 2019
UNKNOWN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 16, 2012
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·December 19, 2019
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·December 19, 2019
2520274-2013-06208
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·September 6, 2013
2520274-2013-06206
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·September 6, 2013
REPLY
FDA Adverse Event
Death
·SORIN BIOMEDICA CRM S.R.L.·Product code DXY·October 10, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 11, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 14, 2017
SYNERGY VERSITREL
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 11, 2015
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 26, 2023
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020