41 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481120893·LOCATOR R-Tx Abutment For UF(II) Narrow Platfor...
ELMED
FDA UDI
ELMED INCORPORATED·00842180184343·FORCEPS, JEWELLER FIG. 5 11CM, 0.15MM
BONASTENT® Tracheal/Bronchial
FDA UDI
Sewoon Medical Co., Ltd.·08806369468527·
Zinnanti Surgical
FDA UDI
Zinnanti Surgical Design Group Inc·G3731405050·6" Smoke Evac Fusion 5mm x 5mm Loop
ZILVER 635 BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FRESENIUS 2008T HEMODIALYSIS MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BELLATEK® ABUTMENT TSV 3.5MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 31, 2026
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·February 5, 2021
IMPELLA 5.5
FDA Adverse Event
Malfunction
·ABIOMED, INC.·Product code OZD·November 20, 2025
CADD SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 13, 2024
ABUTMENT, PATIENT SPECIFIC, TITANIUM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 26, 2017
HAKIM PROGRAMMABLE VALVE W/PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·May 31, 2013
NA
FDA Adverse Event
Injury
·Product code LNH·June 21, 2011
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·August 28, 2008
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
IMPELLA 5.5 WITH SMARTASSIST S2 SET, US
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·February 20, 2026
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
PUMP 381 PUMP SET (US)
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 13, 2026