16 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
RCSP RETROGRADE CANNULA
FDA Adverse Event
Injury
·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·November 13, 2013
AXIAL RING HANDLE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896007352·AXIAL RING HANDLE WITHOUT RATCHET
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746108112·DB BKT MINI MS UL LAT 022 T+9 A+9 R=0
AXIAL RING HANDLE
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929010740·AXIAL RING HANDLE WITHOUT RATCHET
NexGen®
FDA UDI
Zimmer, Inc.·00889024201897·
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 3, 2024
ION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 30, 2014
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·November 10, 2010
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·October 19, 2012
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·March 4, 2019
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·January 24, 2019
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY MODULAR SPIKE ARM POST, REF 00-5901-074-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
FDA Recall
Terminated
·Zimmer Inc.·Product code MBH·March 14, 2011
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