11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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syngo Application Software
FDA 510(k)
FDA Class 2
·Radiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197073080·Weitlaner-Beckmann Retractor,
14.0 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197073110·Weitlaner-Beckmann Retractor,
24.0 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197073097·Weitlaner-Beckmann Retractor,
16.0 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197073103·Weitlaner-Beckmann Retractor,
20.0 c...
QUICK VUE RSV TEST, MODELS 20193, 20199
FDA 510(k)
FDA Class 1
·Microbiology
CONTREX PLUS LOW CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 14, 2013
BIRD
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BZR·June 22, 2011
CONCORDE VBR 9X7X27MM
FDA Adverse Event
Malfunction
·DEPUY SPINE, INC.·Product code MQP·September 15, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018