21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
M-SERIES PRO CPAP SYTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SLEEPEASY
FDA Adverse Event
Injury
·RESPIRONICS INC.·Product code BZD·April 12, 2012
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 6, 2010
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·November 25, 2009
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
REMSTAR PLUS M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·March 16, 2012
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·February 24, 2010
REMSTAR PLUS M
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 21, 2010
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·December 1, 2010
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 26, 2011
Armada
FDA UDI
Nuvasive, Inc.·00887517209115·ARM15T Rod, 110mm Conventional Pre-Bent
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849011·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192251·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
SPL CRIMP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DRI ECSTASY ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code FZX·April 11, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·September 2, 2014
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 1, 2011
2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2023
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011