11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042242·ALISEA 70, SIZE ML, MOKA, GRADUATED COMPRESSION...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809871128·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
POLESTAR N-10
FDA 510(k)
FDA Class 2
·Radiology
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 9, 2013
ZIMMER UNIVERSAL LOCKING SYSTEM SCREW
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HWC·February 15, 2011
CONTAK RENEWAL 4
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013