11 results · 21ms · Sources: EU EUDAMED, 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