21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FRYE & CO
FDA UDI
FGX INTERNATIONAL INC.·00193033474587·
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 30, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·February 11, 2026
LEAD BLOCKS
FDA 510(k)
FDA Class 2
·Radiology
ARTHREX BIO-TRANSFIX
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
50-13172 SPECIAL PROCEDURE TRAY #6957
FDA Adverse Event
Other
·DEROYAL INC·Product code LRO·February 12, 2001
50-13172 SPECIAL PROCEDURE TRAY #6957
FDA Adverse Event
Other
·DEROYAL INC·Product code LRO·February 12, 2001
50-13172 SPECIAL PROCEDURE TRAY #6957
FDA Adverse Event
Injury
·DEROYAL INC.·Product code LRO·February 12, 2001
50-13172 SPECIAL PROCEDURE TRAY #6957
FDA Adverse Event
Injury
·DEROYAL INC.·Product code LRO·February 12, 2001
50-13172 SPECIAL PROCEDURE TRAY #6957
FDA Adverse Event
Malfunction
·DEROYAL INC.·Product code LRO·February 12, 2001
50-13172 SPECIAL PROCEDURE TRAY #6957
FDA Adverse Event
Other
·DEROYAL INC·Product code LRO·February 12, 2001
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·March 20, 2013
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code DTK·March 10, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 12, 2008
PENUMBRA SMART COIL DETACHMENT HANDLE
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·August 28, 2020
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·September 8, 2021
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 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