64 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline Cautery Tip Cleaner
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Anti-D (RH1) IgM+IgG
FDA UDI
DIAGAST·23661562105261·Blood Grouping Reagent, Anti-D (Human/Murine Mo...
ELMED
FDA UDI
ELMED INCORPORATED·00842180187696·5MM,45CM, OPEN-FLAT TIPPED IRRIGATION/SUCTION C...
ELMED
FDA UDI
ELMED INCORPORATED·00198506057069·Westphal gall duct forceps. Curved. Delicate, l...
MODIFICATION TO THE GRIP
FDA 510(k)
FDA Class 2
·Cardiovascular
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
FDA 510(k)
FDA Class 3
·Cardiovascular
VIDAS CMV IGM 30 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LKQ·April 30, 2021
VIDAS CMV IGM 30 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LKQ·April 30, 2021
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 27, 2022
VIDAS CMV IGM 30 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LKQ·March 8, 2021
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 31, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 27, 2026
ARCHITECT TOXO IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 19, 2026
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·October 4, 2023
DURALOC CONST LINER 52X28
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·October 22, 2008
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 10, 2011
FORTIFY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 8, 2026
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·March 4, 2026
ALINITY I TOXO IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 2, 2026