81 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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DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017798·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017781·K-Wire, Double Ended, Trocar Point, Diameter Si...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704967·Bozeman Uterine Dressing Forceps, 10-1/4" (25.6...
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
FDA 510(k)
FDA Class 2
·General Hospital
FREEDOM HP
FDA 510(k)
FDA Class 1
·Physical Medicine
NAIL HOLDING SCRE WGAMMA3 8X35MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 3, 2014
M2A-MAGNUM MOD HD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 31, 2013
UNIVERSAL HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS INAGI·Product code LFL·June 17, 2011
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
COVIDIEN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026
BAKRI TAMPONADE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code OQY·March 27, 2018
BAKRI TAMPONADE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code OQY·May 14, 2018
PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
BAKRI TAMPONADE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code OQY·December 4, 2018
BAKRI TAMPONADE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code OQY·November 5, 2018
BAKRI TAMPONADE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code OQY·October 29, 2018
COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
FDA Adverse Event
Malfunction
·COOK INC·Product code OQY·October 2, 2018