14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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