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

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PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIMENSION GARANT L, DIMENSION GARANT L QUICK

FDA 510(k)
FDA Class 2 ·Dental

ELECSYSCA 15-3 II ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

CADD CASSETTE RESERVOIR

FDA Adverse Event
Malfunction ·ICU MEDICAL MANUFACTURING S.A. DE C.V.·Product code FPA·October 28, 2025

CADD CASSETTE RESERVOIR

FDA Adverse Event
Malfunction ·ICU MEDICAL MANUFACTURING S.A. DE C.V.·Product code FPA·October 28, 2025

CADD MEDICATION CASSETTE

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC·Product code FPA·September 10, 2025

CADD MEDICATION CASSETTE RESERVOIR

FDA Adverse Event
Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·July 28, 2025

CADD MEDICATION CASSETTE RESERVOIR

FDA Adverse Event
Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·July 28, 2025

SPECTRA WAVEWRITER?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 28, 2025

ZIMMER DOUGH-TYPE BONE CEMENT 40GM/20ML

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code LOD·April 17, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·April 27, 2011

GYNECARE MORCELLEX TISSUE MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·July 2, 2008

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015