13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G-THAWKIT BLAST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·May 12, 2021
ULTAMET MTL INS NEUT 36MM 52OD
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWA·April 11, 2013
MEDEFIL
FDA Adverse Event
Injury
·MEDEFIL·Product code NZW·May 23, 2008
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 12, 2011
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code KRO·December 1, 2021
AS ENDURO FEMORAL COMPONENT CEMENTED F1R
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·September 1, 2021
ENDURO MENISCAL COMPONENT F3 10MM
FDA Adverse Event
Injury
·AESCULAP AG·Product code KRO·August 4, 2021
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code HRZ·August 10, 2022
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010
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