21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMAGEGRID RADIOLOGY VIEWER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
URETEX SUP PUBOURETHRAL SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 19, 2024
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 3, 2013
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·September 16, 2014
XIA LP MONOAXIAL SCREW 7.5 X 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code NKB·April 20, 2011
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 5, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
ROD Ø5.5 SOFT CURV L70 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·November 6, 2013
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012