10 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
FDA 510(k)
FDA Unclassified
·Unknown
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305981·Diamond medium grit
Synergy Health AST, LLC
FDA registration
Synergy Health AST, LLC·51 products·🇺🇸 United States
5F GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 2, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·March 18, 2011
CONTOUR TS TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 15, 2008
LIFEWISE BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·RADIOSHACK·Product code DXN·October 20, 2004
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