11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
FDA 510(k)
FDA Class 1
·General Hospital
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
JETSTREAM ATHERECTOMY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·June 30, 2022
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 22, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 17, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 26, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018