10 results
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17ms
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Sources: EU EUDAMED, US FDA
COOKED MEAT MEDIUM WITH IRON
FDA 510(k)
FDA Class 1
·Microbiology
GC Initial™
FDA UDI
Gc America Inc.·15400556701888·GC Initial™ MC Inside IN-42 Terracota, 50g
GC Initial™
FDA UDI
Gc America Inc.·J0228706421·GC Initial™ MC Inside IN-42 Terracota, 50g
AERONEB PROFESSIONAL NEBULIZER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
GRAVITY Soft Tissue Repair System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN KNEE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 12, 2014
ETHICON
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 7, 2010
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 12, 2012
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017