11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VitalFlow Console
FDA 510(k)
FDA Class 2
·Cardiovascular
EarQ
FDA UDI
Sbo Hearing A/S·05714464029945·EARQ F40 MINIRITE T C090
MDPC-8127
FDA 510(k)
FDA Class 2
·Pathology
DEROYAL GOWNS, STERILE, NON-STERILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLITAIRE AB STENT
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NJE·April 1, 2022
AUTOCAT 2 WAVE JAPANESE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·November 7, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·September 1, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 16, 2013
NATUS EMBLA NDX AMPLIFIER
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code GWQ·August 26, 2020
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage
FDA Recall
Terminated
·Cure Medical LLC·Product code EZD·November 11, 2014