11 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
FDA 510(k)
FDA Class 1
·General Hospital
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LNM·October 17, 2012
COAPTITE
FDA Adverse Event
Other
·MERZ AESTHETICS, INC·Product code LNM·October 17, 2012
COAPTITE INJECTABLE IMPLANT
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LNM·October 17, 2012
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
FDA 510(k)
FDA Class 2
·Orthopedic
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 17, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 27, 2013
3 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 11, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·April 5, 2008
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