15 results · 19ms · Sources: EU EUDAMED, US FDA

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CARDS O.S. MONO

FDA 510(k)
FDA Class 2 ·Immunology

icotec Lumbar Cage PLIF 0° / 25 mm x 10 mm

FDA UDI
icotec AG·07640164848242·icotec Lumbar Cage PLIF 0° / 25 mm x 10 mm

ENDOCLAMP AORTIC CATHETER

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code DXC·June 23, 2006

SMARTLENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 24, 2022

WALLSTENT RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

VITROS 5600 INTEGRATED SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·May 30, 2017

TRILOGY 202

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·May 7, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·November 12, 2010

RIATA ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

WALLSTENT? RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012