188 results
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7ms
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Sources: EU EUDAMED, US FDA
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·October 4, 2017
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
impression coping, repositionable, short, screw-retained, PF 4.0
FDA Enforcement
Class II
·Ongoing·Thommen Medical AG·March 27, 2024
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 4, 2020
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·October 4, 2017
Index Coping Surgical Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Standard Abutment Transfer Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Pick-Up Impression Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Locator Abutment Impression Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
IOL Transfer Impression Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Conical EP Pick-Up Coping (Hexed) Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Conical Abutment Pick-up Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Standard Abutment Pick -Up Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
IOL Pick-Up Impression Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain EP Pick-Up Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Implant Twist Lock TM Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain Twist Lock TM Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain EP Twist Lock TM Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain EP Twist Lock TM Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016