13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORE-FLO D/C
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
FDA 510(k)
FDA Class 2
·General Hospital
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 12, 2023
PLMA DVC C11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 26, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 16, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 18, 2011
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 5, 2010
PINNACLE MTL INS NEUT 36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 5, 2010
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 5, 2010
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
MDLR CNLTD TRIDRV DRVR
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·August 29, 2023
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