19 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305481·Diamond, cone rounded edge, medium grit
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
FDA 510(k)
FDA Class 2
·Neurology
PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
FDA 510(k)
FDA Class 3
·Cardiovascular
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 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
CONTOUR THREAD OR CONTOUR THREADS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009
HAKIM INLINE PROGRAMMABLE VALVE SG
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·April 2, 2013
CURITY 3.0MM CUFFED
FDA Adverse Event
Injury
·COVIDIEN / FORMERLY TYCO HEALTHCARE·Product code JOH·March 18, 2011
E360 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 15, 2008
SILVERHAWK BTK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MCW·November 6, 2020
SPIDER FX
FDA Adverse Event
Injury
·COVIDIEN·Product code NTE·November 6, 2020
BTK TURBOHAWK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MCW·November 6, 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