25 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AAP LOQTEC CLAVICLE PLATES 2.7/3.5
FDA 510(k)
FDA Class 2
·Orthopedic
Vliwasorb
FDA UDI
Huizhou Foryou Medical Devices Co., Ltd.·06940610104757·
ARTHREX SWIVELOCK ANCHORS
FDA 510(k)
FDA Class 2
·Orthopedic
PIONEER U121 SERIES CPAP
FDA 510(k)
FDA Class 2
·Anesthesiology
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·March 6, 2017
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 27, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·December 1, 2016
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 25, 2017
90 DEG CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·October 14, 2016
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·October 21, 2016
BIOMNET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·September 23, 2016
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·March 20, 2017
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 12, 2017
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·July 11, 2017
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 12, 2017
CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·December 15, 2016