12 results
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27ms
·
Sources: EU EUDAMED, US FDA
MASK, PXYGEN
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77814131·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77814131001·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77814130101·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77814130051·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
uDR 592h, uDR 596i
FDA 510(k)
FDA Class 2
·Radiology
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PDS+ V 45 CM M0.7 G-2
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·January 10, 2022
RESTORATION ADM X3 INS 28/58
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·April 30, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·October 10, 2012
V-CATH PICC
FDA Adverse Event
Other
·NEOMEDICAL·Product code DQY·July 28, 2010
Assurity MRI Model Numbers: PM1272, PM2272 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