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

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NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A

FDA 510(k)
FDA Class 2 ·Radiology

CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1

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

MODEL 4810 ANALYZER OUTPUT ADAPTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUIK-COMBO PACING/DEFIBRILLATION/ECG

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998

DEPUY ASR XL FEM IMP SIZE 49

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 11, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 2, 2014

INRATIO2

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 15, 2011

IMP,1-PC,ANG,3.0X13MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·September 19, 2024

IMP,1-PC,ANG,3.0X13MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 11, 2019

ARCHITECT ANTI-TPO

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025

ARCHITECT ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JZO·May 23, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015