10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DIGITAL ECG HOLTER RECORDER, MODEL DR512
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
Key Scientific Products Incorporated·00850041798028·PEP REAGENT
N/A
FDA UDI
Key Scientific Products Incorporated·00850041798042·Pep ReagentT
SYNCHRON CREATINE KINASE REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code CGS·June 17, 2011
MAKO 7
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN DEPUY STEM
FDA Adverse Event
Injury
·Product code KWY·February 28, 2013
LC PCA NEW 802.11 AB
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·July 2, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 9, 2011
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017