18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MultiCath, AcQRate Dx Fixed Curve Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
16PW - Washington Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White
KATENA
FDA UDI
KATENA PRODUCTS, INC.·00841668123942·Flat Vitrectomy Lens w fixed ring
Symmetry Olsen
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00841785104831·
ZAVATION TAP
FDA UDI
Zavation LLC·00197157021405·MIS Tap 4.5MM
BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code JSH·October 4, 2024
SMILIE PC
FDA 510(k)
FDA Class 1
·Dental
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
FDA 510(k)
FDA Class 2
·Microbiology
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·February 11, 2015
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 8, 2011
FLEXIMA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FFA·October 20, 2017
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Death
·COVIDIEN·Product code OUT·January 9, 2015
CATH PKGD: BERMAN 6 FR 9 0CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQO·August 3, 2011
SORIN S3 ROLLER PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DWB·June 27, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·November 11, 2016
ENDURANT-II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·November 11, 2016
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