12 results
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19ms
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Sources: EU EUDAMED, US FDA
MODIFIED COAG-1 PT TEST CARD
FDA 510(k)
FDA Class 2
·Hematology
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295124088·Antibacterial Strong Strips Adhesive Bandages; ...
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENAMELITE ACRYSEAL SPRAY SEALANT
FDA 510(k)
FDA Class 2
·Dental
DIACAM (510(K) K 901019)
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 30, 2014
MP20 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2010
TOTALCARE SPO2RT
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 30, 2012
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2015
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 9, 2015
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018
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