9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDELA ELECTRIC BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001538·VITROS Immunodiagnostic Products Anti-HIV 1+2 C...
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482032008·Symmetry® Retractor, IMA Epicardial, Medium
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
FDA 510(k)
FDA Class 2
·General Hospital
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·October 23, 2012
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 26, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021