15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Origin Short Neck Collared Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023935·
APEX SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CDB CLIP
FDA 510(k)
FDA Class 2
·Dental
TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018
TM ANKLE TIBIAL INSERT COMPONENT SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018
6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·June 20, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 22, 2011
INTELECT ADVANCED STIM MONOCHROME
FDA Adverse Event
Malfunction
·CHATTANOOGA GROUP·Product code IPF·September 29, 2008
TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
BD MICROLANCE¿ HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·April 15, 2019
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025