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Sources: EU EUDAMED, US FDA
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HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
FDA Recall
Terminated
·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015
System, Test, C-Reactive Protein
FDA classification
FDA Class 2
·System, Test, C-Reactive Protein
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
FDA classification
FDA Class 1
·Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Test, Phencyclidine (Pcp), Over The Counter
FDA classification
FDA Unclassified
·Test, Phencyclidine (Pcp), Over The Counter
Over The Counter Thermal Treatment For Acne.
FDA classification
FDA Class 2
·Over The Counter Thermal Treatment For Acne.
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
FDA Recall
Terminated
·Maquet SAS Parc De Limere Avenue De La Pomme De Pin Orleans France·Product code FTD·June 14, 2018
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
FDA Recall
Terminated
·Maquet SAS Parc De Limere Avenue De La Pomme De Pin Orleans France·Product code FTD·April 19, 2018
Over-The-Counter Powered Light Based Laser For Acne
FDA classification
FDA Class 2
·Over-The-Counter Powered Light Based Laser For Acne