13 results · 22ms · Sources: EU EUDAMED, US FDA

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SURGI-WRAP MAST BIORESORBABLE SHEET

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

SNAZZY2

FDA 510(k)
FDA Class 2 ·Physical Medicine

BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018

AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025

UNSPECIFIED SAFESET TRANSPAC SETS

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

UNSPECIFIED CENTRAL LINE TRANSDUCER SET

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·November 5, 2024

AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·April 10, 2013

E-POLY 40MM +3 HIWALL LINER SZ24

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MAY·September 4, 2014

SYNCHROMED EL

FDA Adverse Event
Malfunction ·RICE CREEK MFG.·Product code LKK·June 13, 2008

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