11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS WORKING ELEMENT FOR PROBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
FDA 510(k)
FDA Class 2
·Dental
CONTINUOUS FLUSH DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
STELLANT
FDA Adverse Event
Malfunction
·MEDRAD, INC·Product code DXT·February 28, 2013
COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022