18 results · 24ms · Sources: EU EUDAMED, US FDA

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CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2

FDA 510(k)
FDA Class 2 ·Cardiovascular

Amara View

FDA UDI
Respironics, Inc.·00606959009172·Amara View Mask without Headgear, Medium

Tiche PTA Balloon Dilatation Catheter

FDA UDI
BrosMed Medical Co.,Ltd.·06958481477641·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0106130·Trial, 26 x 13mm, 8 Degree, Tapered, Straight

Phonak

FDA UDI
Phonak AG·07612847818477·Phonak Ambra microP (pure transparent)

RTE SNAPCONE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962108765·PROBE, 5", DOUBLE ENDED, SLIVER

MAGELLAN-2200, MODEL 1

FDA 510(k)
FDA Class 2 ·Anesthesiology

VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100

FDA 510(k)
FDA Class 2 ·Cardiovascular

REAR TIP EXTENDER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025

RTE SNAPCONE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 2, 2013

5MM PEEK MULTIFUNCTION HANDLE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·September 15, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011

NAVARRE UNIVERSAL DRAIN

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code GBX·December 18, 2023

BD MAX¿ CPO

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

BD MAX¿ CPO

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

FDA Enforcement
Class II ·Terminated·ConMed Corporation·April 4, 2018