16 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Indigo® Lightning Flash Aspiration System Select + Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·July 6, 2012
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·October 8, 2013
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·October 8, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 1, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·February 25, 2013
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 26, 2012
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 13, 2016
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 13, 2016
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 18, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·November 10, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 9, 2011
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 22, 2013
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023