11 results · 21ms · Sources: EU EUDAMED, US FDA

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ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE

FDA 510(k)
FDA Class 2 ·Dental

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496051381·ROSSELLA 70 SHEER, SIZE ML, NERO, GRADUATED COM...

CIDEX OPA SOLUTION

FDA 510(k)
FDA Class 2 ·General Hospital

HUMMER IV MICRODEBRIDER SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ACL ADVANCE

FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 10, 2013

ACCU-CHEK FLEXLINK PLUS INFUSION SET

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 4, 2011

ILLUMENA-SYR-W/HF-150ML BX50

FDA Adverse Event
Malfunction ·COVIDIEN·Product code DXT·May 16, 2008

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018