12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IQM Integral Quality Monitor (also IQM)
FDA 510(k)
FDA Class 2
·Radiology
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Uk Ltd·00880304253063·
REPROCESSED DILATING TIP TROCARS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONSET ACCESS CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 14, 2011
QUADRA H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWY·June 5, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·October 10, 2014
32MM MOD HEAD COCR -3MM NECK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·April 11, 2018
RNGLC LNR 32MM 10 DEG 24
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 11, 2018
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024