14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STb Copper Ni-Ti
FDA UDI
ORMCO CORPORATION·00889989025019·STb STRAIGHTWIRE CUNITI 18 x 18 SM PK10
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
FDA 510(k)
FDA Class 2
·Orthopedic
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 4, 2019
SUMMIT DUOFIX TAP SZ7 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code LPH·April 9, 2013
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·April 6, 2011
EASYTRAK 3
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 22, 2017
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