2,723 results
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42ms
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Sources: EU EUDAMED, US FDA
Ivy Biomedical Systems Inc.
System producer
🇺🇸 United States
No. V1 097447 0006
Certificate
IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs
No. V1 097447 0006
Certificate
IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs
No. V1 097447 0006
Certificate
IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
34262
Certificate
MDD Annex II (excluding section 4)·OriGen Biomedical Inc.·GMED SAS·119 Basic UDI-DIs
346262
Certificate
MDD Annex II (excluding section 4)·OriGen Biomedical Inc.·GMED SAS·1 Basic UDI-DI
HL 2147514-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·YASEE BioMedical Inc.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
HL2147514-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·YASEE BioMedical Inc.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
FDA Recall
Open, Classified
·Gauthier Biomedical, Inc.·Product code LXH·November 11, 2024
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Recall
Open, Classified
·Genesee BioMedical, Inc.·Product code DWS·February 26, 2018
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
FDA Recall
Terminated
·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
FDA Recall
Terminated
·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017
NavaClick Syringe and Needle, Model Number LIN02
FDA Recall
Open, Classified
·LINEAGE BIOMEDICAL, INC·Product code FMF·July 12, 2024
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
FDA Recall
Terminated
·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
FDA Recall
Terminated
·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
FDA Recall
Terminated
·Aesthetics Biomedical, Inc.·Product code OUH·March 13, 2020
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
FDA Recall
Terminated
·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
FDA Recall
Open, Classified
·Spark Biomedical Inc·Product code PZR·July 2, 2025
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.
FDA Recall
Completed
·Hycor Biomedical Inc·Product code DHR·February 21, 2018
TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.
FDA Recall
Terminated
·Lifecore Biomedical, Inc.·Product code LYC·June 3, 2004