12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DELFIA NEONATAL IRT KIT, MODEL A005-110
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COALESCENT SURGICAL U-CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GRAFTYS BCP (510K NUMBER: K073064)
FDA Adverse Event
Injury
·GRAFTYS·Product code MQV·July 11, 2013
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 23, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 13, 2011
INVACARE LIFTS AND SLINGS
FDA Adverse Event
Injury
·INVACARE CORPORATION - MANUFACTURING FACILITY·Product code FSA·July 9, 2008
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015