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

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IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

FDA 510(k)
FDA Class 2 ·Immunology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450226292·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450308349·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450286227·

BD LUER-LOK

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 24, 2025

BD SYRINGE 30ML LL S/C 56

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 2, 2025

EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

WARMER 2000LD

FDA 510(k)
FDA Class 1 ·Physical Medicine

PASSPORT MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

L-CATH PICC KIT

FDA Adverse Event
Malfunction ·ARGON MEDICAL DEVICES INC.·Product code LJS·September 3, 2014

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 20, 2011

Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

FDA Enforcement
Class II ·Terminated·Arrow International Inc·June 14, 2017

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

FDA Enforcement
Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

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