20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809869927·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
NEUROMAP WITH NEURO 100
FDA 510(k)
FDA Class 2
·Neurology
DISCOVERY FACET SCREW FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
HARMONIC ACE 36 CM
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 7, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 5, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 31, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 29, 2012
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
FLEXTEND IS-1 BI POSITIVE FIX
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
TEMPBOND CLEAR WITH TRICLOSAN
FDA Adverse Event
Injury
·KERR COPORATION·Product code EMA·April 6, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 15, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 14, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 12, 2015
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 31, 2012
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.
FDA Recall
Terminated
·Hansen Medical Inc·Product code DXX·December 4, 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