50 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Handpiece Headquarters
FDA registration
Handpiece Headquarters·6 products·🇺🇸 United States
HENRY SCHEIN
FDA Adverse Event
Injury
·HANDPIECE HEADQUARTERS·Product code EFB·March 21, 2024
MIDWEST
FDA Adverse Event
Injury
·HANDPIECE HEADQUARTERS·Product code EFB·March 21, 2023
W&H
FDA Adverse Event
Injury
·HANDPIECE HEADQUARTERS·Product code EFB·April 17, 2025
MAXIMA PRO 45 N/O FIXED END
FDA Adverse Event
Injury
·HANDPIECE HEADQUARTERS·Product code EFB·October 1, 2022
DARBY
FDA Adverse Event
Injury
·HANDPIECE HEADQUARTERS·Product code EFB·December 28, 2023
MAXIMA PRO 45 N/O FIXED END
FDA Adverse Event
Injury
·HANDPIECE HEADQUARTERS·Product code EFB·September 7, 2022
HENRY SCHEIN PRECISION-TORQUE
FDA Adverse Event
Malfunction
·HANDPIECE HEADQUARTERS INC.·Product code EFB·May 29, 2019
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
FDA Enforcement
Class II
·Ongoing·Handpiece Headquarters·February 13, 2019
IMPACT AIR 45
FDA Adverse Event
PALISADES DENTAL, LLC·Product code EFB·November 9, 2015
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
FDA Recall
Open, Classified
·Handpiece Headquarters·Product code EBZ·April 4, 2018
BA INTERNATIONAL 1:5 HANDPIECE
FDA Adverse Event
Injury
·B.A. INTERNATIONAL LTD.·Product code EGS·November 12, 2020
RENEW XR HANDPIECE, 34CM
FDA Adverse Event
Malfunction
·MICROLINE SURGICAL INC·Product code GEI·May 20, 2024
BA INTERNATIONAL 1:5 HANDPIECE
FDA Adverse Event
Injury
·B.A. INTERNATIONAL LTD.·Product code EGS·November 12, 2020
NSK X95L
FDA Adverse Event
NAKANISHI INC.·Product code EGS·July 21, 2015
AHP-77C 1:2 ANGLED HANDPIECE
FDA Adverse Event
Injury
·NSK NAKANISHI·Product code EFB·June 23, 2010
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Malfunction
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·June 23, 2023
AQUABEAM ROBOTIC SYSTEM
FDA Adverse Event
Malfunction
·PROCEPT BIOROBOTICS CORPORATION·Product code PZP·July 10, 2023
PROFOUND SYSTEM (FORMERLY KNOWN AS MIRATONE SYSTEM)
FDA Adverse Event
Injury
·SYNERON MEDICAL LTD.·Product code GEI·August 19, 2016
GENTLEMINI LUX 4500 BR
FDA Adverse Event
Injury
·KAVO DENTAL GMBH·Product code EFB·October 10, 2012