16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
FDA 510(k)
FDA Class 2
·Cardiovascular
Raw Surgical Corporation
FDA UDI
RAW SURGICAL CORPORATION·G508RSC40518050·KERRISON RONGEURS, 5mm, 40° up-cutting, Shaft L...
Acapella One
FDA UDI
Choice Spine, LP·00840996150842·ACAPELLA,TRIAL,LR,NS,14X18X5
SEAL & PROTECT PROTECTIVE SEALANT
FDA 510(k)
FDA Class 2
·Dental
BLU-U, MODEL 4170
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·April 10, 2013
VERSACARE
FDA Adverse Event
HILL-ROM RITTER·Product code FNL·April 24, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 12, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·December 6, 2010
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010
BD LUER-LOK TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 8, 2021
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-125.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·December 20, 2004
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