15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
Cook
FDA UDI
COOK INCORPORATED·00827002076181·Connector for Gastrostomy Tubes
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFE SCOPE P, MODEL BSM-4100 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
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 GAW·September 23, 2009
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
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 8, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011
VITALITY DR HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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