34 results
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30ms
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Sources: EU EUDAMED, US FDA
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
FDA 510(k)
FDA Unclassified
·Unknown
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502532·MR-Adapter Siemens CP Head Array
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101352·SS Suture, 6 per sleeve
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735343·Hayden Chisel, 5" (12.7cm) solid octagon handle...
SURGIC IV IMPLANT CONTROL UNIT
FDA 510(k)
FDA Class 1
·Dental
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
FDA 510(k)
FDA Class 1
·Ophthalmic
ZEPHIR® ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 11, 2012
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTL, LTD.·Product code KWA·December 29, 2010
INVACARE MOBILAIRE
FDA Adverse Event
Malfunction
·GARDNER DENVER THOMAS INC.·Product code CAF·April 3, 2013
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·February 15, 2011
COCHLEAR IMPLANT
FDA Adverse Event
Injury
·UNKNOWN·Product code MCM·May 7, 2008
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·August 21, 2013
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·October 24, 2015
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·August 21, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 2013