8,285 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
FDA 510(k)
FDA Class 2
·General Hospital
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814305·GENUMEDI PT SILVER R VII
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZE·January 6, 2014
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
FDA Enforcement
Class II
·Terminated·Zimmer Dental Inc·February 5, 2014
ORATECT ORAL FLUID DRUG SCREEN DEVICES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT
FDA 510(k)
FDA Class 2
·Dental
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10 MM 3/ BOX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·May 8, 2013
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2011
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 26, 2024
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 19, 2019
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 7, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 29, 2026
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 23, 2022
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 11, 2022
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 20, 2026
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026