11 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FD TENS 2030, MODEL DFJ24T
FDA 510(k)
FDA Class 2
·Neurology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450246405·
Valkyrie Rib Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391347·Rib Screw, Ø2.8 x 13mm, Qty. 3
Valkyrie Rib Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391330·Rib Screw, Ø2.8 x 13mm, Qty. 1
Valkyrie Rib Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391354·Rib Screw, Ø2.8 x 13mm, Qty. 8
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 11, 2013
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·May 27, 2008
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
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