54 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEAK
FDA 510(k)
FDA Class 2
·Dental
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192183·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100257·CHU ASPIRATING SPECULUM SOLID
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197031059·Metzenbaum-Fino Scissors Fig. 1
straig...
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RHEAD RADIAL HEAD EXTENDED STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
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
TRULIANT TIB IMP PSC INSERT SZ 6, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
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
BELT CLIP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 7, 2013
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2011
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
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 30, 2022