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

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Enteral Feeding Sets

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LCP

FDA UDI
Synthes GmbH·10886982164490·4.5MM LCP PROXIMAL TIBIA PLATE 6 HOLES/118MM-LEFT

Vagus Nerve Stimulator For Rheumatoid Arthritis

FDA Pre-Market Approval
FDA Class 3 ·SetPoint System

POLYCRYL

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

NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Vagus Nerve Stimulator For Rheumatoid Arthritis

FDA Pre-Market Approval
FDA Class 3 ·SetPoint System

Vagus Nerve Stimulator For Rheumatoid Arthritis

FDA Pre-Market Approval
FDA Class 3 ·SetPoint System

I-STAT EG7+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 29, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 8, 2011

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

FDA Adverse Event
Injury ·BARD SHANNON LTD·Product code FTL·July 18, 2013

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Malfunction ·AGA MEDICAL CORPORATION·Product code MLV·November 16, 2020

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Malfunction ·AGA MEDICAL CORPORATION·Product code MLV·November 16, 2020

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Malfunction ·AGA MEDICAL CORPORATION·Product code MLV·November 16, 2020

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013