21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
FDA 510(k)
FDA Class 2
·Hematology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257024386·OMOMED SHOULDER SUP SILVER LEFT SIZE III
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032203·Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs B...
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
FDA 510(k)
FDA Class 2
·General Hospital
CLAY-PARK LABS, INC. - LUBRICATING JELLY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
XORAN
FDA Adverse Event
Malfunction
·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014
SCP CONTROL PANEL
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022
STOCKERT JMS CENTRIFUGAL PUMP SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
12MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·April 3, 2013
HANDPIECE 1896200 STRAIGHTSHOT MAGNUM
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HRX·March 29, 2011
BRAVO
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code FFT·April 21, 2008
STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM
FDA Adverse Event
Injury
·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +
FDA Recall
Terminated
·Siemens Medical Systems Inc·Product code JAK·July 10, 2002
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012