21 results · 22ms · Sources: EU EUDAMED, US FDA

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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