32 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RN Impression Post for closed-tray impression,for screw-retained abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600304586·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036138714·
SIMPLICITY DISPOSABLE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
A-WEAR
FDA 510(k)
FDA Class 2
·Dental
BD SAF-T-INTIMA SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN
FDA Adverse Event
Injury
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·August 13, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·November 28, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 22, 2018
TBD
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 16, 2013
TRACER METRO DIRECT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KOG·March 18, 2011
CORTEX SCREW S.T.
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·June 13, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 21, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 3, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 15, 2021