22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CrossTIE Intraosseous Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131288059·H330V2, DESIGNRITE 10 WL CRED HHM
Light Cure Adhesive
FDA UDI
TP ORTHODONTICS INC·00192029000083·ADHESIVE, BRACKET-Tooth Conditioner, Resin
Prolift Post-Pack Instruments
FDA UDI
Life Spine, Inc.·00190837031923·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111134036·DISSECTING SCISSORS STR 4 1/4"
REUSABLE STIMULATING ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
FDA 510(k)
FDA Class 2
·General Hospital
TRULIANT TIB IMP PSC INSERT SZ 6, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
SPRINTER LEGEND RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code LOX·June 7, 2013
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·October 8, 2014
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
ALK (D5F3)
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC.·Product code NJT·August 22, 2025
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 24, 2024
ADVANCED PATELLA 29M 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 14, 2023
ADVANCED PATELLA 32MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 19, 2025
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 19, 2023
TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 6, 2023
ADVANCED PATELLA 35MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 9, 2024
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016