20 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074033488·BONE SCREW 7042855 20 DEG ILC 8.5X55 TI
LIQUISPX LIQUID LIPID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2027971-2022-042855
FDA Adverse Event
Injury
·NOBEL BIOCARE USA, LLC·Product code DZE·February 18, 2022
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·January 21, 2016
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008
CONTOUR THREAD
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 15, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Injury
·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·April 4, 2013
CENTURY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 30, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009
CALCIUM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013