12 results
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19ms
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Sources: EU EUDAMED, US FDA
QUANTA LITE RUBEOLA (MEASLES) IGG
FDA 510(k)
FDA Class 1
·Microbiology
Sklar
FDA UDI
SKLAR CORPORATION·10649111118661·MILLER-COLBURN RASP PL/SERR SIZE 1
Grappler Interference Screw System
FDA UDI
Paragon 28, Inc.·00889795141521·1.6 X 20cm, Eyelet K-wire w/ Markings
Grappler Interference Screw System
FDA UDI
Paragon 28, Inc.·00889795153180·Ø1.60mm x 20cm Eyelet Kirschner Wire, 316 LVM
Vu a-POD Prime NanoMetalene
FDA UDI
Seaspine Orthopedics Corporation·10889981139483·Prime NM Implant, 39x27mm x 16mm, 20 Deg
PiCCO Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ALKALINE PHOSPHATASE ISOENZY. SUB. SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOPATH DILATING TIP TROCAR
FDA Adverse Event
Malfunction
·EES-JUAREZ·Product code GCJ·February 20, 1997
SAGITTAL SAW ATTACHMENT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 21, 2013
AP STANDARD RAPID-PORT EZ
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·January 25, 2011
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 31, 2014
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 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