7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NK PINCH SENSOR, MODEL PF002
FDA 510(k)
FDA Class 2
·Orthopedic
SALTER LABS MODIFIED NEBUTECH NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General Hospital
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·January 14, 2013
UNKNOWN SCD
FDA Adverse Event
Other
·COVIDIEN·Product code JOW·November 24, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 3, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015