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

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ST. MARK'S RECTAL BIOPSY FORCEPS

FDA 510(k)
FDA Class 1 ·Gastroenterology, Urology

Tranquil-C™

FDA UDI
NEXUS SPINE, L.L.C.·B6788224010·Cervical Trial + DS 6x12x12 Flat

Halyard

FDA UDI
O&M HALYARD, INC.·20680651682240·HALYARD,H400,STRWRP,-,24X24,250

TANGO M2 BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

PTS PANELS MULTI-CHEMISTRY CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

ASR UNI FEMORAL IMPL SIZE 41

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code LFL·August 17, 2007

Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021

ACCOLADE SR SL MRI (Model L310)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025