11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABX PENTRA 400: LIPOPROTEINS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REMEL
FDA UDI
REMEL, INC.·00848838007040·Dubos Polysorbate Albumin Broth 100/PK
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70608541·BioQuick-Brackets McLaugh/Benn/Trev. .022" 200 ...
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
FDA 510(k)
FDA Class 1
·General Hospital
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON LABORATORIES, INC. / HUNTINGTON·Product code HQL·May 9, 2007
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 5, 2013
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 6, 2014
WECK VISISTAT SKIN STAPLER, DISPOSABLE, 35W
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDT·March 11, 2011
Contour¿ next GEN Blood Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024