18 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDS Bioceramic Sealer (Bioseal)
FDA 510(k)
FDA Class 2
·Dental
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)
24M - Salt River Project-21 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112663·BARRON CORNEAL PUNCH 8.75MM
APS INPUT OUTPUT MODULE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JQP·June 12, 2017
STELKAST PROVEN KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 18, 2022
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 15, 2014
JELCO
FDA Adverse Event
Injury
·SMITHS MEDICAL·Product code FMF·June 26, 2013
ELLIPSE VR ICD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·November 4, 2015
INNOVA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIP·December 2, 2022
INNOVA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIP·December 8, 2022
ENDURANT II EXTENSION CUFF
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 30, 2022
ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·January 23, 2026
ENDURANT II STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 2, 2022
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·February 4, 2026
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