24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 1
·Dental
Oticon
FDA UDI
Oticon A/S·05707131165237·ACPR, ITC/ITE AT WL L BE ACTO PRO
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450525791·
DEBAKEY SATINSKY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896003446·DEBAKEY SATINSKY CLAMP DOUBLED ANGLE JAW
DEBAKEY SATINSKY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921007850·DEBAKEY SATINSKY CLAMP DOUBLED ANGLE JAW
Indus®
FDA UDI
SPINEFRONTIER, INC.·00190361001492·Invue Max, Four Level ACP, 85mm
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047954·
Zavation
FDA UDI
Zavation LLC·00197157002060·8.5mm Tap
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494463556·Endoscopic Kerrison Punch
D 3.5mm, 40°, WL 150mm
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047916·
Portex
FDA UDI
ICU MEDICAL, INC.·15019315047930·
SLEEP APP
FDA 510(k)
FDA Class 2
·Dental
KSEA DION-GRACIA SET
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 10, 2018
UNKNOWN IV CATHETER
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·January 13, 2016
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014
EON IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 19, 2011
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013