10 results
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23ms
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Sources: EU EUDAMED, US FDA
STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW
FDA 510(k)
FDA Class 2
·General Hospital
Safco CleanCare Essential Prophy Paste
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063753884·Safco CleanCare Essential prophy paste,coarse b...
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
TIPOWER POWERDRIVE AND RIMPOWER X & SX
FDA 510(k)
FDA Class 2
·Physical Medicine
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·March 27, 2013
JETSTREAM G3
FDA Adverse Event
Injury
·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·March 16, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 31, 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
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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