11 results · 23ms · Sources: EU EUDAMED, US FDA

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SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TRIO LX SMALL CONNECTOR

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TEH LIN JUPITER POWER CHAIR, MODEL TL-320

FDA 510(k)
FDA Class 2 ·Physical Medicine

INFUSOMAT SPACE

FDA Adverse Event
Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 17, 2013

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·June 18, 2008

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 12, 2011

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24

FDA Enforcement
Class II ·Ongoing·ICU Medical Inc.·September 10, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015