17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PCP-USB STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606067·SPACER 2132560 OLIF25 27MM 12 DEG 16X60
RC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600381204·
Bernafon
FDA UDI
Bernafon AG·05711584050873·CA5 ITC, R BE CARISTA 5
CASTROVIEJO CORNEAL SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014428·CASTROVIEJO CORNEAL SCISSORS STRONG CURVED BLADE
AXOGUARD NERVE CONNECTOR AND PROTECTOR
FDA Adverse Event
Injury
·COOK BIOTECH·Product code JXI·August 24, 2015
ARROWHEAD SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED PULSE OXIMETER SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·September 27, 2021
ACCU-CHEK ® TENDER INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FPA·October 1, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 29, 2013
TI LCP DISTAL FEMUR PLATE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·June 10, 2011
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017
AXOGUARD NERVE CONNECTOR AND PROTECTOR
FDA Adverse Event
Injury
·COOK BIOTECH·Product code JXI·October 24, 2019
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 12, 2025
OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - 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