21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119769·OLIF, 34mm X 11mm X 14mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119721·OLIF, 34mm X 11mm X 10mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119714·OLIF, 34mm X 11mm X 9mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119707·OLIF, 34mm X 11mm X 8mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119776·OLIF, 34mm X 11mm X 15mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119691·OLIF, 34mm X 11mm X 7mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119738·OLIF, 34mm X 11mm X 11mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119783·OLIF, 34mm X 11mm X 16mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119745·OLIF, 34mm X 11mm X 12mm, Convex, T3
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523119752·OLIF, 34mm X 11mm X 13mm, Convex, T3
POLYFLUX 17L
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER·Product code KDI·January 14, 2020
OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·December 18, 2023
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 9, 2013
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·April 7, 2011
CONTAK RENEWAL 3 RF HE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
NUVASIVE HELIX ACP SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·June 1, 2022
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026