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

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Corelink Navigation Instruments

FDA 510(k)
FDA Class 2 ·Neurology

Oticon

FDA UDI
Oticon A/S·05707131332882·OPN 3, KIT 312 2.4G NFM R C001

ML24000 UVA-1 PHOTOTHERAPY CABINET

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

DIGIFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

I-STAT EC4+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 3, 2008

AORTIC FLEX

FDA Adverse Event
Injury ·MEDTRONIC ATS MEDICAL·Product code LWQ·June 21, 2013

PLUM XLM W/MODIFD B

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 11, 2011

URETERAL BRUSH BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FDX·November 15, 2023

URETERAL BRUSH BIOPSY SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FDX·January 7, 2022

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024