18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALPHA CRYPTOCOCCAL ANTIGEN EIA
FDA 510(k)
FDA Class 2
·Microbiology
ArgenPMMA Multi 98x12-B4
FDA UDI
ARGEN CORPORATION, THE·D818120946·Crown And Bridge, Temporary, Resin
WeightRight®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020869·Tungsten-Filled Hurst Esophageal Dilator, 46 Fr...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450313091·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450314043·
ADPER PROMPT
FDA 510(k)
FDA Class 2
·Dental
INTRAVSCULAR ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
HAHN TAPERED IMPLANT Ø4.3 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 22, 2024
HAHN TAPERED IMPLANT Ø4.3 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 30, 2024
TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018
TM ANKLE TIBIAL INSERT COMPONENT SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 13, 2011
IN TOUCH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC, LP·Product code FNL·August 13, 2008
TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018