10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00811801035197·25 mm Pedicle Marker - Smooth, 2.0 mm
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
FDA 510(k)
FDA Class 2
·General Hospital
EVANS SUB-Q, MODEL MC4206
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 27, 2013
CRYSTALENS HD
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·March 16, 2011
GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·April 2, 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