25 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BL4.6 Screw-retained Abutment Digital Analog
FDA UDI
BIO CONCEPT Co., Ltd.·06947600309154·
Oticon
FDA UDI
Oticon A/S·05707131305916·DYNAMO SP6, BTE 13 WL 110 CBE DEMO
ENDO-MODEL SL KNEE PROSTHESIS SYSTEM CONNECTION COMPONENT, ROTATIONAL VERSION
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·November 8, 2018
CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·March 30, 2021
CONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·December 15, 2020
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359233·Connection Components,Rotational version, neutral
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359257·Connection Components,Rotational version, neutral
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359240·Connection Components,Rotational version, neutral
PATIENT EXAMINATION GLOES
FDA 510(k)
FDA Class 1
·General Hospital
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·November 26, 2020
ENDO-MODEL SL
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·August 29, 2023
CONNECTION COMPONENT ROTATIONAL VERSION, SMALL
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·July 19, 2021
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 11, 2013
SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER W/ AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DQE·July 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026