7 results
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6ms
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Sources: EU EUDAMED, US FDA
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
FDA Enforcement
Class II
·Terminated·Sybron Dental Specialties·September 18, 2013
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
FDA Enforcement
Class II
·Terminated·Allesee Orthodontic Appliances·April 9, 2014
Amerigel Wound Dressing 1 oz. tube
FDA Enforcement
Class II
·Terminated·Kova Laboratories, Inc.·July 16, 2014
Amerigel Wound Dressing 55 gallons/drum
FDA Enforcement
Class II
·Terminated·Kova Laboratories, Inc.·July 16, 2014
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
FDA Enforcement
Class II
·Terminated·Kowa Optimed Inc·December 23, 2020