16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
FDA 510(k)
FDA Class 2
·Cardiovascular
artegral life
FDA UDI
Merz Dental GmbH·D7091993257·anteriors; shade B3; mould UIL
TORQMAX SHEATH GRIP ACCESSORY
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUSON Sequoia Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 7, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·August 8, 2014
DURAL ALPHA INSERT W RIM II/32
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LPH·March 12, 2019
DURASUL, ALPHA INSERT, HOODED, II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·September 28, 2018
METASUL, ALPHA INSERT, JJ/28
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 4, 2019
DURASUL, ALPHA INSERT, KK/36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
COCR HEAD 32/ 0 'M' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·June 4, 2019
DURASUL, ALPHA INSERT, LL/36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 29, 2019
DURASUL, ALPHA INSERT, HOODED, KK/32
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LPH·June 15, 2018
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014