21 results · 20ms · Sources: EU EUDAMED, 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