38 results · 26ms · Sources: EU EUDAMED, US FDA

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OSI O-BALL ABUTMENT HEAD IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

FDA 510(k)
FDA Class 2 ·Neurology

SARA STEDY

FDA Adverse Event
Malfunction ·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·April 8, 2013

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014

SYNCHRON LX® I 725 CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 1, 2011

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

AMISTEM H FEMORAL STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 12, 2012

LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 13, 2023

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·December 17, 2024

LOGIC FEMORAL PS CEM LEFT SZ 3.5

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·March 5, 2025

LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·June 30, 2022

LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 5, 2024

LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 11, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·October 26, 2023

OPTETRAK LOGIC

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 7, 2023

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 11, 2023

INSERT TIBIA LOGIC PSC SZ3 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 7, 2020

LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·July 30, 2024