9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOVE GUARD MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AT WORK DRUG TEST, MODEL 9177T AWT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BOYD DELIVERY UNIT
FDA 510(k)
FDA Class 1
·Dental
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHA·May 6, 2011
HEPARIN
FDA Adverse Event
Injury
·Product code NZW·July 22, 2008
1000317571-2021-00127
FDA Adverse Event
Injury
·CONVATEC LTD·Product code FRO·March 17, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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