13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
ArgenZ HT+ 98x22 A3
FDA UDI
ARGEN CORPORATION, THE·D818122075·Dental porcelain/ceramic restoration kit
EndoFlex
FDA UDI
MERLYN ASSOCIATES, INC.·00182151000570·7.5mm ID oral/nasal endotracheal tube with infl...
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981029678·CONTOURED CROSSBAR, LARGE, 5.5 ROD
CONTOURED CROSSBAR LARGE 5.5 ROD
FDA Adverse Event
Malfunction
·SEASPINE, INC.·Product code KWP·April 28, 2014
VITEK 2 STRPTOCOCCUS AMPICILLIN
FDA 510(k)
FDA Class 2
·Microbiology
DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
FDA 510(k)
FDA Class 2
·Cardiovascular
ALLEGRETTO EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·May 16, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 19, 2014
GE MR/CT SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA - CINCINNATI·Product code HBL·May 24, 2011
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020