15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY C-STEM AMT
FDA 510(k)
FDA Class 2
·Orthopedic
CIRCUITGUARD CIRCUITGUARD HME
FDA Adverse Event
Other
·ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE·Product code BYD·July 20, 2005
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
IMPL TAPERED SP 3.7MM 12M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 10, 2024
IMPL TAPERED SP 3.7MM 12M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMPL TAPERED SP 4.8MM 8MM OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 10, 2024
LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·April 29, 2013
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 9, 2011
ABBOTT COMMANDER PPC
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JQW·July 23, 2008
IMPL TAPERED SP 3.7MM 10M M OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 27, 2023
IMPL TAPERED SP 4.8MM 8MM OCTAGON
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·March 3, 2023
PRESIDIO 10 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014